search
Back to results

Cardiopulmonary Bypass Prime Solution in Patients Undergoing Heart Valve Surgery

Primary Purpose

Heart Valve Diseases

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Six percent hydroxy ethyl starch 130/0.4
Ringer lactate
Sponsored by
Rajaie Cardiovascular Medical and Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Valve Diseases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rajaie CMRC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Hydroxy ethyl starch (HES)

Ringer lactate (RL)

Arm Description

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

Ringer lactate as priming solution during CPB

Outcomes

Primary Outcome Measures

Number of participants required blood transfusion
The volume of blood transfusion after heart valve surgery

Secondary Outcome Measures

Number of participants died in hospital
Any cause of death after heart valve surgery
Duration of ventilation time
The duration ventilation time after heart valve surgery
ICU length of stay
The length of stay in intensive care unit
Hospital length of stay
The length of stay in hospital after heart valve surgery
Number of participants required chest tube drainage
The amount of drainage from chest tube after heart valve surgery
Number of participants required re-operation for bleeding
Re-operation due to excessive bleeding after heart valve surgery
Number of participants died in one month
Any cause of death within one month after heart valve surgery
Changes in hemoglobin concentration
Changes in hemoglobin after heart valve surgery
Changes in hematocrit concentration
Changes in hematocrit after heart valve surgery
Changes in serum lactate concentration
Changes in serum lactate after heart valve surgery
Changes in serum blood sugar concentration
Changes in serum blood sugar after heart valve surgery
Number of participants with acute kidney injury
The development of acute kidney injury after heart valve surgery
Changes in liver enzyme concentration
Changes in liver enzyme after heart valve surgery
Amount of cerebral hemispheres' oxygenation
The amount of cerebral oxygenation measured by INVOS in both hemispheres
Changes in coagulation parameters
Changes in coagulation parameters after heart valve surgery

Full Information

First Posted
January 8, 2022
Last Updated
January 23, 2022
Sponsor
Rajaie Cardiovascular Medical and Research Center
Collaborators
Heart Valve Disease Research Center
search

1. Study Identification

Unique Protocol Identification Number
NCT05223361
Brief Title
Cardiopulmonary Bypass Prime Solution in Patients Undergoing Heart Valve Surgery
Official Title
Cardiopulmonary Bypass Prime Solution in Patients Undergoing Heart Valve Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rajaie Cardiovascular Medical and Research Center
Collaborators
Heart Valve Disease Research Center

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Valve Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydroxy ethyl starch (HES)
Arm Type
Active Comparator
Arm Description
Six percent hydroxy ethyl starch 130/0.4 additive to ringer lactate as priming solution during CPB
Arm Title
Ringer lactate (RL)
Arm Type
Active Comparator
Arm Description
Ringer lactate as priming solution during CPB
Intervention Type
Drug
Intervention Name(s)
Six percent hydroxy ethyl starch 130/0.4
Intervention Description
6% HES 130/0.4 additive to ringer lactate as prime solution
Intervention Type
Drug
Intervention Name(s)
Ringer lactate
Intervention Description
Ringer lactate as prime solution
Primary Outcome Measure Information:
Title
Number of participants required blood transfusion
Description
The volume of blood transfusion after heart valve surgery
Time Frame
Up to discharge, an average of 8 days
Secondary Outcome Measure Information:
Title
Number of participants died in hospital
Description
Any cause of death after heart valve surgery
Time Frame
Up to discharge, an average of 8 days
Title
Duration of ventilation time
Description
The duration ventilation time after heart valve surgery
Time Frame
During ICU admission, an average of 2 days
Title
ICU length of stay
Description
The length of stay in intensive care unit
Time Frame
During ICU admission, an average of 2 days
Title
Hospital length of stay
Description
The length of stay in hospital after heart valve surgery
Time Frame
During hospital admission, an average of 8 days
Title
Number of participants required chest tube drainage
Description
The amount of drainage from chest tube after heart valve surgery
Time Frame
During hospital admission, an average of 8 days
Title
Number of participants required re-operation for bleeding
Description
Re-operation due to excessive bleeding after heart valve surgery
Time Frame
During hospital admission, an average of 8 days
Title
Number of participants died in one month
Description
Any cause of death within one month after heart valve surgery
Time Frame
One month after surgery
Title
Changes in hemoglobin concentration
Description
Changes in hemoglobin after heart valve surgery
Time Frame
Up to 48 hours after heart valve surgery
Title
Changes in hematocrit concentration
Description
Changes in hematocrit after heart valve surgery
Time Frame
Up to 48 hours after heart valve surgery
Title
Changes in serum lactate concentration
Description
Changes in serum lactate after heart valve surgery
Time Frame
Up to 48 hours after heart valve surgery
Title
Changes in serum blood sugar concentration
Description
Changes in serum blood sugar after heart valve surgery
Time Frame
Up to 48 hours after heart valve surgery
Title
Number of participants with acute kidney injury
Description
The development of acute kidney injury after heart valve surgery
Time Frame
Up to 48 hours after heart valve surgery
Title
Changes in liver enzyme concentration
Description
Changes in liver enzyme after heart valve surgery
Time Frame
Up to 48 hours after heart valve surgery
Title
Amount of cerebral hemispheres' oxygenation
Description
The amount of cerebral oxygenation measured by INVOS in both hemispheres
Time Frame
During cardiopulmonary bypass time
Title
Changes in coagulation parameters
Description
Changes in coagulation parameters after heart valve surgery
Time Frame
Up to 48 hours after heart valve surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Rajaie CMRC
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
We will decide per request.

Learn more about this trial

Cardiopulmonary Bypass Prime Solution in Patients Undergoing Heart Valve Surgery

We'll reach out to this number within 24 hrs