Cardiopulmonary Bypass Prime Solution in Patients Undergoing Heart Valve Surgery

NCT05223361 | Completed Phase 3 DMC

• 1 other identifier: HVDRC-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Valve Diseases

Outcome Measures

Primary Outcomes (1)

• Number of participants required blood transfusion

  The volume of blood transfusion after heart valve surgery

  Up to discharge, an average of 8 days

Secondary Outcomes (15)

• Number of participants died in hospital

  Up to discharge, an average of 8 days

• Duration of ventilation time

  During ICU admission, an average of 2 days

• ICU length of stay

  During ICU admission, an average of 2 days

• Hospital length of stay

  During hospital admission, an average of 8 days

• Number of participants required chest tube drainage

  During hospital admission, an average of 8 days

Study Arms (2)

Hydroxy ethyl starch (HES)

ACTIVE COMPARATOR

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; Drug: Ringer lactate

Ringer lactate (RL)

ACTIVE COMPARATOR

Ringer lactate as priming solution during CPB

Drug: Ringer lactate

Interventions

Six percent hydroxy ethyl starch 130/0.4 DRUG

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

Hydroxy ethyl starch (HES)

Ringer lactate DRUG

Ringer lactate as prime solution

Hydroxy ethyl starch (HES); Ringer lactate (RL)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rajaie Cardiovascular Medical and Research Center: lead
• Heart Valve Disease Research Center: collaborator

Study Sites (1)

Rajaie CMRC

Tehran, Iran

Location

MeSH Terms

Conditions

Heart Valve Diseases

Interventions

Ringer's Lactate

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rajaie Cardiovascular Medical and Research Center

Study Record Dates

• First Submitted: January 8, 2022
• First Posted: February 3, 2022
• Study Start: April 1, 2016
• Primary Completion: April 30, 2021
• Study Completion: November 30, 2021
• Last Updated: February 3, 2022

Record last verified: 2022-01

Locations

IR (1)