Cardiopulmonary Bypass Prime Solution in Patients Undergoing Heart Valve Surgery

Heart Valve Diseases Clinical Trial

Official title:

Cardiopulmonary Bypass Prime Solution in Patients Undergoing Heart Valve Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05223361
• Other study ID #: HVDRC-01
• Status: Completed
• Phase: Phase 3
• Start date: April 2016
• Est. completion date: November 30, 2021

Study information

• Verified date: January 2022
• Source: Rajaie Cardiovascular Medical and Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Valve Diseases

Intervention

Drug:
• Six percent hydroxy ethyl starch 130/0.4
6% HES 130/0.4 additive to ringer lactate as prime solution
• Ringer lactate
Ringer lactate as prime solution

Locations

Country	Name	City	State
Iran, Islamic Republic of	Rajaie CMRC	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Rajaie Cardiovascular Medical and Research Center	Heart Valve Disease Research Center

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants required blood transfusion	The volume of blood transfusion after heart valve surgery	Up to discharge, an average of 8 days
Secondary	Number of participants died in hospital	Any cause of death after heart valve surgery	Up to discharge, an average of 8 days
Secondary	Duration of ventilation time	The duration ventilation time after heart valve surgery	During ICU admission, an average of 2 days
Secondary	ICU length of stay	The length of stay in intensive care unit	During ICU admission, an average of 2 days
Secondary	Hospital length of stay	The length of stay in hospital after heart valve surgery	During hospital admission, an average of 8 days
Secondary	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
Secondary	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
Secondary	Number of participants died in one month	Any cause of death within one month after heart valve surgery	One month after surgery
Secondary	Changes in hemoglobin concentration	Changes in hemoglobin after heart valve surgery	Up to 48 hours after heart valve surgery
Secondary	Changes in hematocrit concentration	Changes in hematocrit after heart valve surgery	Up to 48 hours after heart valve surgery
Secondary	Changes in serum lactate concentration	Changes in serum lactate after heart valve surgery	Up to 48 hours after heart valve surgery
Secondary	Changes in serum blood sugar concentration	Changes in serum blood sugar after heart valve surgery	Up to 48 hours after heart valve surgery
Secondary	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
Secondary	Changes in liver enzyme concentration	Changes in liver enzyme after heart valve surgery	Up to 48 hours after heart valve surgery
Secondary	Amount of cerebral hemispheres' oxygenation	The amount of cerebral oxygenation measured by INVOS in both hemispheres	During cardiopulmonary bypass time
Secondary	Changes in coagulation parameters	Changes in coagulation parameters after heart valve surgery	Up to 48 hours after heart valve surgery