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Ann Thorac Surg 2004;78:1332-1337
© 2004 The Society of Thoracic Surgeons

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Original article: cardiovascular

Fenoldopam Prophylaxis of Postoperative Acute Renal Failure in High-Risk Cardiac Surgery Patients

^a Cardiothoracic Anesthesia and Intensive Care, Istituto Policlinico S. Donato, Milan, Italy
^b Cardiac Surgery Intensive Care Unit, Azienda Ospedaliera S. Croce and Carle, Cuneo, Italy
^c Anesthesia and Intensive Care Unit, Villa Maria Pia Hospital, Turin, Italy
^d Anesthesia and Intensive Care I, Ospedali Riuniti, Bergamo, Italy
^e Cardiac Anesthesia and Intensive Care, Spedali Civili, Brescia, Italy
^f Cardiovascular Intensive Care Unit, Ospedale Mauriziano Umberto I, Turin, Italy
^g Cardiovascular Anesthesia and Intensive Care, IRCCS San Raffaele Hospital, Milan, Italy
^h Anesthesia and Intensive Care, IRCCS Centro Cardiologico Monzino, Milan, Italy
ⁱ Anesthesia and Intensive Care A, Ospedale di Circolo e Fondazione Macchi, Varese, Italy

Accepted for publication February 18, 2004.

^* Address reprint requests to Dr Ranucci, Cardiothoracic Anaesthesia Department, Istituto Policlinico S. Donato, Via Morandi 30, 20097 San Donato Milanese, Milan, Italy
cardioanestesia{at}virgilio.it

	Abstract

Top Abstract Introduction Patients and Methods Comment Acknowledgments References

 
BACKGROUND: Acute renal failure requiring replacement therapy occurs in 1% to 2% of patients who have undergone cardiac surgery with cardiopulmonary bypass and is associated with a very high mortality rate. The aim of this study was to determine if prophylactic treatment with fenoldopam mesylate of patients at high risk of postoperative acute renal failure reduced the incidence of this event.

METHODS: This was a multicenter, prospective, cohort study in which 108 patients at high risk of postoperative acute renal failure and undergoing cardiac surgery with cardiopulmonary bypass were treated with fenoldopam mesylate (0.08 µg · kg^–1 · min^–1) starting at the induction of anesthesia and throughout at least the next 24 hours. A homogeneous control group of 108 patients was created using a propensity-score analysis.

RESULTS: Fenoldopam prophylaxis was significantly associated with a reduction in acute renal failure incidence (from 22% to 11%, p = 0.028), a less pronounced creatinine clearance decrease (p = 0.05), and a lower mortality rate (6.5% versus 15.7%, p = 0.03) by the univariate analysis, but these results were not confirmed by a multivariable analysis. Within the subgroup of patients who suffered a postoperative low output syndrome, fenoldopam prophylaxis was an independent protective factor for postoperative renal failure (odds ratio, 0.14; 95% confidence interval, 0.03 to 0.7; p = 0.017).

CONCLUSIONS: Given the limitations of a nonrandomized prospective trial, our results support the hypothesis that fenoldopam may reduce the risk of acute renal failure in patients in whom endogenous and exogenous cathecolamines action may induce a renal vascular constrictive condition.

	Introduction

Top Abstract Introduction Patients and Methods Comment Acknowledgments References

 
Acute renal failure (ARF) requiring postoperative renal replacement therapy (RRT) occurs in 1% to 2% of patients who have undergone cardiac operations [1, 2] and is associated with a very high (greater than 50%) mortality rate [1, 3]. Numerous risk factors have been identified as independent predictors of ARF after cardiac surgery: age [1, 2, 4–7]; preoperative serum creatinine levels [1, 2, 4–8]; diabetes [1, 2, 4–6]; congestive heart failure [2, 5]; urgent operation, need for preoperative intraaortic balloon pump (IABP) support [7]; cardiopulmonary bypass (CPB) duration [4–6]; low hematocrit values during CPB [8, 9]; and low output syndrome in the postoperative course [7, 8, 10]. In spite of the great deal of literature exploring the risk profile for ARF after cardiac surgery, little information is available regarding possible preventive strategies. Owing to the relatively low incidence of ARF, clinical trials focused on preventive strategies would have to involve a large number of patients.

Fenoldopam mesylate (Corlopam; Abbott Laboratories, Abbott Park, IL) is a short-acting dopamine-1 agonist with antihypertensive properties. It appears to improve renal function in clinical situations of reduced blood flow [11–14] by increasing renal blood flow to both the cortex and medullary region. Despite its potential benefit in the setting of ARF after cardiac surgery, however, there are few reports of its use in this clinical environment [15, 16]. These authors suggest a possible preservation of renal function in patients perioperatively treated with fenoldopam, but their results are based on case series [15] or explore renal function (serum creatinine and creatinine clearance) without addressing postoperative ARF [16].

The aim of the present study is to investigate the role of prophylactic fenoldopam administration to patients undergoing cardiac surgery, who are at high risk of needing postoperative renal replacement therapy for ARF (RRT-ARF).

	Patients and Methods

Top Abstract Introduction Patients and Methods Comment Acknowledgments References

 
Study Design, Patient Population, and Power of Study
This was a multicenter, prospective cohort study. Nine centers participated in the study. Institutional Review Board approval and written consent from the patients were obtained. Five of the nine centers were already using fenoldopam in an attempt to improve renal function during cardiac surgery and as a systemic vasodilator, but with different protocols. The other four did not use fenoldopam before the initiation of the study. From June 2002, the nine centers agreed to apply the same fenoldopam prophylactic treatment to all patients meeting the entry criteria. The study was not a randomized prospective trial because the five institutions already using fenoldopam considered it unethical to deprive patients of this drug.

The primary endpoint of this study was the incidence of RRT-ARF. This was defined as ARF treated with continuous venovenous hemofiltration (that was the routine first choice renal replacement therapy in all nine institutions). Secondary endpoints were renal function, general outcome, and hospital mortality. As the incidence of RRT-ARF is relatively low in the general cardiac surgical population, the experimental hypothesis (ie, that prophylactic fenoldopam use significantly reduces postoperative RRT-ARF incidence) would require the investigation of a very large number of patients. We therefore decided to include in this study only patients at high risk of ARF. The most significant preoperative risk factor for RRT-ARF in cardiac surgery is the serum creatinine level [1, 2, 4–8]. To determine the predictable incidence of ARF at various levels of preoperative serum creatinine, we explored the data from the National Cardioanesthesia Data Base [17]. A preoperative serum creatinine level of 1.8 mg/dL or more determines a risk of RRT-ARF of 12% (relative risk, 7.1; 95% confidence interval [CI], 5.4 to 9.3). In presence of other risk factors (age >70 years, diabetes, ejection fraction <0.4) the predicted risk rises to 38% (95% CI, 11 to 64) [17].

We considered a preoperative serum creatinine value of 1.8 mg/dL or more as the primary entry criterion; at least one secondary entry criterion (age, diabetes, low ejection fraction) was needed to enter the study. For the power analysis, we considered that the predictable RRT-ARF incidence was 20%, and applied as experimental hypothesis a reduction to 6.5% (one third) in fenoldopam-treated patients. With an value of 0.05 and a ß value of 0.2, the power analysis identified a population size of 96 patients for each group. We therefore decided to compare two groups (fenoldopam and control groups) of at least 100 patients and no more than 120 patients each.

Exclusion criteria were preoperative dialysis, age less than 18 years, heart transplant operations, and known allergy to fenoldopam mesylate.

All patients in the fenoldopam group received a continuous intravenous infusion of fenoldopam mesylate (0.08 µg · kg^–1 · min^–1) starting at the induction of anesthesia and throughout at least the next 24 hours.

The control group was created retrospectively looking in each institution at the files of patients for the 18 months before starting the fenoldopam prophylaxis (untreated), demonstrating the same primary entry criterion (preoperative serum creatinine level 1.8 mg/dL), at least one secondary entry criterion, and no exclusion criteria. To adjust for dishomogeneity of the groups, a propensity score analysis was applied (see Appendix), and a homogeneous group of control patients was consequently created.

Perioperative Management
All the patients were treated according to the local policy regarding anesthesia and intensive care unit treatment. No limitation was imposed as to the use of other vasodilators, inotropic agents, diuretics, nor mechanical support with IABP according to the clinical status of the patient. Cardiopulmonary bypass management and myocardial protection did not differ from the usual standard of each participating institution. Fluid administration followed the standard protocols of each participating institution. The decision of instituting a renal replacement treatment was undertaken on the basis of the standard protocols of each participating institution.

Data Collection and Definitions
Preoperative variables are listed in Table 1, intraoperative variables in Table 2, and postoperative variables in Table 3. Radiocontrast agents were considered if used within the previous 72 hours; the surgical operations were divided into isolated coronary artery bypass graft or open heart procedure (isolated valve surgery or combined coronary coronary and valve surgery); biocompatible treatment was defined as use of any type of coating of the circuit and oxygenator (heparin, phosphorylcholine, other agents); mean perfusion pressure less than 60 mm Hg was considered if present for more than 15 consecutive minutes; low-dose dopamine was defined as less than 3 µg · kg^–1 · min^–1; dopamine at higher doses and epinephrine were defined as catecholamines, and enoximone and levosimendan were considered other inotropic agents; lung dysfunction was defined as the need for prolonged mechanical ventilation due to poor arterial blood gases when trying to wean the patient; low output syndrome was divided in two groups according to the need for inotropic treatment alone (inotropic agents) or for IABP placement. Creatinine clearance before and after the operation was calculated with the Cockcroft-Gault equation [18].

Determinants of RRT-ARF were explored with an univariate analysis (Student's t test and Pearson's ²). Factors being significantly associated with RRT-ARF at a level of p less than 0.05 were admitted to a multivariate logistic regression analysis (stepwise forward) to define a predictive model for RRT-ARF in our population of high-risk patients. Statistical software (SPSS version 11.0; SPSS, Chicago, IL) was used for all the statistical calculations.

Results
Homogeneity of the groups for preoperative variables was checked (Table 1) and no significant difference between groups was detected. With respect to operative variables (Table 2), patients in the control group were treated with low-dose dopamine at a significantly higher rate than patients in the fenoldopam group; patients in the fenoldopam group demonstrated a significantly higher urine output during CPB.

The postoperative course in the two experimental groups is shown in Table 3. The following significant differences were seen: a lower rate of patients needing diuretics during the intensive care unit stay in fenoldopam group; a less pronounced decrease of creatinine clearance in the fenoldopam group; and a lower incidence of RRT-ARF and hospital mortality in the fenoldopam group.

The risk of RRT-ARF was addressed looking at all the potential predictors (see Table 4). Ten predictors have been identified at the univariate analysis. Six of them had a strong (p < 0.001) intercorrelation: ejection fraction, cardiogenic shock, preoperative use of IABP, heparin pretreatment, urgent operation, and postoperative low output syndrome. The first five significantly concurred in determining a low cardiac output state, that was the major determinant of RRT-ARF both in terms of odds ratio and significance. To avoid collinearity and overfitting of the model, the multivariable model included only the low output state and the other four variables (preoperative serum creatinine level, lowest hematocrit on CPB, CPB duration, need for transfusions), together with the grouping variable (fenoldopam treatment). A stepwise forward multivariate logistic regression analysis was applied, and two factors remained as independent predictors of RRT-ARF: preoperative serum creatinine level and low cardiac output syndrome (Table 5). At this analysis, fenoldopam prophylaxis did not confirm its protective role on RRT-ARF incidence (p = 0.063). Low cardiac output syndrome was the main determinant of RRT-ARF, both in terms of odds ratio (8.6) and significance (p = 0.001). We therefore decided to apply a posthoc analysis to the subgroup of patients affected by postoperative low cardiac output syndrome (Table 5) (requiring major inotropic treatment or IABP) in order to identify the effect of fenoldopam treatment in a population at very high risk of RRT-ARF. The subgroup comprised 70 patients, with 25 patients (35.7%) who had RRT-ARF. In this subgroup (Table 6), fenoldopam prophylaxis was an independent protective factor of RRT-ARF, with an odds ratio of 0.14 (95% CI, 0.03 to 0.7), thus demonstrating a sevenfold lower likelihood of RRT-ARF in high-risk patients with a low output syndrome after cardiac surgery. Urgent surgery carries a significantly higher risk (odds ratio, 17; 95% CI, 2 to 152) of RRT-ARF. In patients without postoperative low cardiac output syndrome, fenoldopam treatment was not correlated with RRT-ARF (p = 0.77).

	Comment

Top Abstract Introduction Patients and Methods Comment Acknowledgments References

The primary endpoint of this study was to determine whether fenoldopam prophylaxis exerted an independent significant protective effect in a population at high preoperative risk of postoperative RRT-ARF. In this regard, our study was shown to be underpowered, and we could only identify a beneficial effect of fenoldopam prophylaxis at the univariate analysis, not at the multivariable approach. Given the detected differences in RRT-ARF (22% versus 11%), the correct number of patients to be enrolled would have been in the range of 150 in each group.

In a posthoc analysis considering patients at high perioperative risk for RRT-ARF, fenoldopam prophylaxis exerted an independent protective effect in patients with postoperative low cardiac output syndrome. Other secondary effects in the total population were a more effective diuresis during CPB, less need for diuretics during the intensive care unit stay, and better presevation of creatinine clearance.

From a time-related point of view, we could identify three subsequent significant effects of fenoldopam treatment: (1) an increased urine output during CPB, (2) a limited decrease in creatinine clearance from preoperative to postoperative determination, and (3) a lower incidence of RRT-ARF at the univariate analysis in the overall population and at the multivariate analysis in patients with postoperative low output syndrome.

Fenoldopam increases renal blood flow, and this effect is probably at the basis of the increased urine output during CPB. Cardiopulmonary bypass has been considered a potential risk factor for renal ischemia, even if its role has been considered secondary by some authors [7, 19, 20]. However, Zanardo and associates [7] found an inverse relationship between urine output during CPB and the degree of renal dysfunction after cardiac operations. In our series, we could find only a borderline inverse correlation (p = 0.064) between urine output during CPB and RRT-ARF, but it is likely that a larger number of patients could result in the confirmation of the protective effect of diuresis during CPB against renal failure in the postoperative course.

After the operation, the preservation of renal function was confirmed in the fenoldopam group by the preserved creatinine clearance; however, the major determinant of RRT-ARF after the operation is low cardiac output syndrome. This condition generally induces a compensatory vasoconstriction that results in reduced renal blood flow and consequent renal dysfunction. Moreover, this state is exacerbated by the use of exogenous catecholamines that further increase the peripheral and visceral arterial resistances. It is therefore not surprising that in our series, as well in other studies [7, 8, 10], a low output state requiring major and prolonged catecholamine support or even the need for IABP is associated with a severe risk of RRT-ARF.

In this setting of endogenous and exogenous vasoconstrictive pattern, fenoldopam is an independent protective factor against RRT-ARF. It is reasonable to hypothesize that the prerenal vasodilating effect of fenoldopam [11–14] may effectively counteract the splanchnic vasoconstriction generally considered as a major determinant of acute renal failure. In absence of this vasoconstrictive pattern, other factors may be advocated to induce a renal function impairment, namely, hemodilution during CPB, that has been recently claimed as a strong determinant of renal function impairment [8, 9], and that even in our series was significantly correlated with RRT-ARF at the univariate analysis in the overall population. As a matter of fact, in patients not haviang postoperative low cardiac output syndrome, fenoldopam treatment totally lost its protective effect.

As a side observation, patients in the control group received low-dose dopamine in 51% of cases (significantly more than fenoldopam-treated patients), in the classic attempt to promote renal vasodilation and possibly a protective effect on renal function. The results of the present study seem to confirm the lack of effectiveness of this approach [21, 22].

We are aware of the major limitations of our study. First, the study was not a prospective randomized trial. The propensity score analysis provided an homogeneous control group, but there could be a time effect on the results, albeit a small one, as the control group comes from an earlier period. Second, multivariable models always carry some limitations: interactions and collinearity may interfere with the final model; and overfitting of data must be considered and is a limitation of sample size. Third, fenoldopam was applied as a prophylactic treatment before the onset of postoperative low cardiac output syndrome, and therefore, we cannot know whether fenoldopam treatment applied once low cardiac output syndrome is established is able to induce the same beneficial effects in terms of RRT-ARF prevention.

In conclusion, this study demonstrates that for patients at high risk of postoperative ARF, fenoldopam exerts an independent protective effect only when a low cardiac output state occurs. A large prospective randomized trial is required to definitively state the role of fenoldopam in preventing ARF after cardiac surgery.

	Appendix

 
Propensity Score Analysis for Homogeneity of Groups
Patients in the fenoldopam group (n = 108) and historical controls from the six participating centers (n = 423) have been analyzed with respect to their "propensity" to be a fenoldopam-treated patient. Creating a homogeneous control group was a three-step procedure:

Step 1. Identification of significant differences between fenoldopam-treated patients and historical controls with a univariate analysis (Pearson ² for categorical variables and unpaired Student's t test for continuous variables). Nine risk factors were significantly different between groups: unstable angina, congestive heart failure, urgent operation, preoperative use of intra-aortic balloon pump (IABP), preoperative bilirubin level, diabetes, failed coronary angioplasty, valvular surgery, and lowest temperature on cardiopulmonary bypass (CPB).

Step 2. Multivariate analysis of the previously identified risk factors. A stepwise logistic regression analysis was applied, with the fenoldopam treatment as a dependent variable and the nine risk factors as independent variables. Five risk factors remained as independent predictors of fenoldopam treatment: preoperative bilirubin level, diabetes, urgent operation, preoperative IABP, and valvular procedure. On the basis of the logistic equation, the propensity score for being a fenoldopam-treated patient was assessed (range, 0 to 1).

Step 3. The fenoldopam-treated patients were divided into quintiles with respect to their propensity score. First quintile (0 to 0.19), 12 patients; second quintile (0.2 to 0.39), 44 patients; third quintile (0.4 to 0.59), 23 patients; fourth quintile (0.6 to 0.79), 16 patients; and fifth quintile (0.8 to 1.0), 13 patients.

The control group was created by randomly including the same number of patients in each propensity score-based quintile.

	Acknowledgments

Top Abstract Introduction Patients and Methods Comment Acknowledgments References

 
This study was supported in part by a research grant from Elan Pharmaceutical Italy.

	References

Top Abstract Introduction Patients and Methods Comment Acknowledgments References

 

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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Ranucci, M. Articles by Uslenghi, M. F. Search for Related Content PubMed PubMed Citation Articles by Ranucci, M. Articles by Uslenghi, M. F. Related Collections Extracorporeal circulation Related Article