Cardiopulmonary Bypass Prime Solution in Patients Undergoing Heart Valve Surgery

NCT ID: NCT05223361

Last Updated: 2022-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2021-11-30

Brief Summary

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

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.

Conditions

Heart Valve Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Hydroxy ethyl starch (HES)

Six percent hydroxy ethyl starch 130/0.4 additive to ringer lactate as priming solution during CPB

Group Type: ACTIVE_COMPARATOR

Six percent hydroxy ethyl starch 130/0.4

Intervention Type: DRUG

6% HES 130/0.4 additive to ringer lactate as prime solution

Ringer lactate

Intervention Type: DRUG

Ringer lactate as prime solution

Ringer lactate (RL)

Ringer lactate as priming solution during CPB

Group Type: ACTIVE_COMPARATOR

Ringer lactate

Intervention Type: DRUG

Ringer lactate as prime solution

Interventions

Six percent hydroxy ethyl starch 130/0.4

6% HES 130/0.4 additive to ringer lactate as prime solution

Intervention Type: DRUG

Ringer lactate

Ringer lactate as prime solution

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heart Valve Disease Research Center

UNKNOWN

Sponsor Role: collaborator

Rajaie Cardiovascular Medical and Research Center

OTHER

Sponsor Role: lead

Responsible Party

Rajaie cardiovascular medical & research center

Rajaie Cardiovascular Medical and Research Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rajaie CMRC

Tehran, , Iran

Countries

Iran

Other Identifiers

HVDRC-01

Identifier Type: -

Identifier Source: org_study_id