Cardiopulmonary Bypass Prime Solution in Patients Undergoing Heart Valve Surgery

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.

Study Overview

• Status: Completed
• Conditions: Heart Valve Diseases
• Intervention / Treatment: Drug: Six percent hydroxy ethyl starch 130/0.4; Drug: Ringer lactate

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Rajaie CMRC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hydroxy ethyl starch (HES); 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; 6% HES 130/0.4 additive to ringer lactate as prime solution; Drug: Ringer lactate; Ringer lactate as prime solution
Active Comparator: Ringer lactate (RL); Ringer lactate as priming solution during CPB	Drug: Ringer lactate; Ringer lactate as prime solution

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rajaie Cardiovascular Medical and Research Center
• Collaborators: Heart Valve Disease Research Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: January 8, 2022
• First Submitted That Met QC Criteria: January 23, 2022
• First Posted (Actual): February 3, 2022

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: January 23, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases
• Other Study ID Numbers: HVDRC-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: We will decide per request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No