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Cardiopulmonary Bypass Prime Solution in Patients Undergoing Heart Valve Surgery

NCT05223361 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-02-03

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Heart Valve Disease Research Center

    collaborator UNKNOWN

  • Rajaie Cardiovascular Medical and Research Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2021-04-30
Completion
2021-11-30

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05223361 on ClinicalTrials.gov