Starch or Saline After Cardiac Surgery

Study Overview
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Brief Summary
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When people undergo major surgery, they require intravenous supplementation of fluids for a number of reasons: to compensate for no oral intake to support blood pressure and organ function during and after surgery to replace lost fluid or blood volume There are a variety of fluid choices doctors have to provide to patients, and it is still not definitively known whether some fluids are better than others in specific situations. This is a particularly interesting question in patients undergoing heart surgery because of the significant volume of fluids used over the entire course of hospitalization, including before the operation, during the operation, and after the operation. There has been some scientific evidence that the use of starch-based fluids (synthetic colloids) leads to better oxygen delivery to the organs with a smaller volume of fluid given, providing for better recovery from surgery. However, there has also been some scientific evidence that the use of these fluids can harm kidney function. Importantly, none of these large-scale studies were carried out specifically in patients undergoing heart surgery. The purpose of this study is to answer the question of whether the use of starch-based fluid in the heart surgery patient makes for a safer and faster recovery, causes kidney dysfunction, or makes no discernable difference.

Official Title
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Short-term Outcomes of Fluid Replacement and Resuscitation Strategy in the Cardiac Surgery Patient: A Randomized, Controlled Trial

Conditions
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Coronary Artery Bypass Surgery

Intervention / Treatment
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* Drug: 6% Hydroxyethyl Starch 130/0.4
* Drug: 0.9% Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing elective primary isolated on-pump coronary artery bypass grafting Exclusion Criteria: pregnant patients patients with an active intra-cranial bleed patients with a history of hypersensitivity to starch solutions patients with Stage 4 or 5 Kidney Disease (estimated glomerular filtration rate < 30 ml / min / 1.73 m2) patients with a significant preoperative metabolic acidosis, defined by a preoperative capillary blood pH less than or equal to 7.2 and a serum bicarbonate less than 15

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Starch group<br>Patients randomized to the Starch group will receive Voluven (6% Hydroxyethyl Starch 130/0.4) for their intravenous bolus and fluid resuscitation requirements. | Drug: 6% Hydroxyethyl Starch 130/0.4<br> <br> |
| Active Comparator: Saline group<br>Patients randomized to the Saline group will receive 0.9% Normal Saline for their intravenous fluid bolus and resuscitation requirements | Drug: 0.9% Normal Saline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute kidney injury as defined by RIFLE criteria |  | Short term (in hospital, up to 30 days) and mid-term (2 months) | 
| Maximum postoperative weight gain |  | Short-term (in hospital, up to 7 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative mortality |  | In hospital (up to 30 days) | 
| Duration of ventilation support requirements |  | In hospital (up to 30 days) | 
| Total chest tube drainage (until removed) |  | In hospital (up to 30 days) | 
| ICU length of stay |  | In hospital (up to 30 days) | 
| Transfusion of blood products |  | In hospital (up to 30 days) | 
| Incidence of atrial fibrillation (necessitating a change in medical management) |  | In hospital (up to 30 days) | 
| Duration of oxygen supplementation |  | In hospital (up to 30 days) | 
| Creatinine, Urea, Cr Clearance as estimated by the MDRD formula |  | In hospital at defined timepoints, and at 2 months post hospital discharge | 
| Volume of fluid infused |  | In hospital (up to 7 days) | 
| Total hospital length of stay (when ready to leave tertiary hospital setting) |  | In hospital | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colloid fluid, crystalloid fluid, surgery, coronary artery bypass grafting, renal function, Patients undergoing coronary artery bypass surgery