Cardiopulmonary Bypass Prime Solution in Patients Undergoing Heart Valve Surgery

Study Overview
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Brief Summary
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In this randomized clinical trial, patients with undergoing open heart valve surgery will be enrolled into the study. Participants will be divided into two groups based on the priming solution type. The first group will receive hydroxyethyl starch (HES) 130/0.4 additive to ringer lactate (RL) and the second group will be given only RL as priming solution. All patients will be observed closely during postoperative days. Through follow up, bleeding/coagulopathy, renal function, hepatic function, and cerebral oxygenation will be recorded in both groups.

Detailed Description
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Cardiopulmonary bypass (CPB) pump is a device for circulating blood in the body while the heart is undergone surgery. For providing circulating volume in the body we need to add about 1.5 to 2 lit fluids as priming solution in the CPB pump. Some fluids mainly included crystalloids, colloids, starch, and gelatin in an only fluid or in a combined formula. During CPB time, the blood dilution is caused by adding prime solution into the circulating volume, and consequently it decreases blood viscosity. Moreover, in addition to a decrease in hematocrit level, coagulation factors and plasma proteins can dramatically decreased. These processes may lead to bleeding events and tissue hypoperfusion and organ damages. To decrease complications, some modalities such as adding colloids to crystalloids have been implemented. On the other hand, any regimen for priming solution has its shortcomings need to be considered based on patient condition and surgical issue. In this double blinded randomized clinical trial study, we aimed to compare the the effects of six percent HES 130/0.4 and RL as priming solutions on coagulation factors, renal function, hepatic function, and cerebral oxygenation in patients undergoing open heart valve surgery.

Official Title
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Cardiopulmonary Bypass Prime Solution in Patients Undergoing Heart Valve Surgery

Conditions
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Heart Valve Diseases

Intervention / Treatment
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* Drug: Six percent hydroxy ethyl starch 130/0.4
* Drug: Ringer lactate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who provided written informed consent and had no heart failure (LVEF >55%), no hepatic failure (defined as aspartate aminotransferase (AST) >40 mg/dL and/or alanine aminotransferase (ALT) >40 mg/dL), no prior history of cardiac surgery, serum creatinine <1.5 mg/dL, no episode of drug-induced acute kidney injury within preoperative 5 days, no severe carotid stenosis in both or one of them, no emergency valvular stenosis, no infective endocarditis, no severe right ventricular failure, no hemoglobin <10 mg/dL, no body mass index >40 kg/m2, no heparin-induced thrombocytopenia, no cancer, no severe pulmonary valve insufficiency, no pulmonary function test <65% before heart valve surgery Exclusion Criteria: included consent withdrawal by the patient or by his/her proxy, allergic reaction to the drugs, the aortic cross clamp time greater than 120 minutes, on-pump time greater than 150 minutes, the performance of the retrograde autologous priming.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hydroxy ethyl starch (HES)<br>Six percent hydroxy ethyl starch 130/0.4 additive to ringer lactate as priming solution during CPB | Drug: Six percent hydroxy ethyl starch 130/0.4<br>* 6% HES 130/0.4 additive to ringer lactate as prime solution<br>Drug: Ringer lactate<br>* Ringer lactate as prime solution<br>|
| Active Comparator: Ringer lactate (RL)<br>Ringer lactate as priming solution during CPB | Drug: Ringer lactate<br>* Ringer lactate as prime solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants required blood transfusion | The volume of blood transfusion after heart valve surgery | Up to discharge, an average of 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants died in hospital | Any cause of death after heart valve surgery | Up to discharge, an average of 8 days | 
| Duration of ventilation time | The duration ventilation time after heart valve surgery | During ICU admission, an average of 2 days | 
| ICU length of stay | The length of stay in intensive care unit | During ICU admission, an average of 2 days | 
| Hospital length of stay | The length of stay in hospital after heart valve surgery | During hospital admission, an average of 8 days | 
| Number of participants required chest tube drainage | The amount of drainage from chest tube after heart valve surgery | During hospital admission, an average of 8 days | 
| Number of participants required re-operation for bleeding | Re-operation due to excessive bleeding after heart valve surgery | During hospital admission, an average of 8 days | 
| Number of participants died in one month | Any cause of death within one month after heart valve surgery | One month after surgery | 
| Changes in hemoglobin concentration | Changes in hemoglobin after heart valve surgery | Up to 48 hours after heart valve surgery | 
| Changes in hematocrit concentration | Changes in hematocrit after heart valve surgery | Up to 48 hours after heart valve surgery | 
| Changes in serum lactate concentration | Changes in serum lactate after heart valve surgery | Up to 48 hours after heart valve surgery | 
| Changes in serum blood sugar concentration | Changes in serum blood sugar after heart valve surgery | Up to 48 hours after heart valve surgery | 
| Number of participants with acute kidney injury | The development of acute kidney injury after heart valve surgery | Up to 48 hours after heart valve surgery | 
| Changes in liver enzyme concentration | Changes in liver enzyme after heart valve surgery | Up to 48 hours after heart valve surgery | 
| Amount of cerebral hemispheres' oxygenation | The amount of cerebral oxygenation measured by INVOS in both hemispheres | During cardiopulmonary bypass time | 
| Changes in coagulation parameters | Changes in coagulation parameters after heart valve surgery | Up to 48 hours after heart valve surgery |