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NCT Number: NCT05223361

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rajaie CMRC

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Six percent hydroxy ethyl starch 130/0.4

Drug

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

Ringer lactate

Drug

Ringer lactate as prime solution

Primary outcomes

  1. Number of participants required blood transfusion

    Time frame: Up to discharge, an average of 8 days

    The volume of blood transfusion after heart valve surgery

Secondary outcomes

  1. Number of participants died in hospital

    Time frame: Up to discharge, an average of 8 days

    Any cause of death after heart valve surgery

  2. Duration of ventilation time

    Time frame: During ICU admission, an average of 2 days

    The duration ventilation time after heart valve surgery

  3. ICU length of stay

    Time frame: During ICU admission, an average of 2 days

    The length of stay in intensive care unit

  4. Hospital length of stay

    Time frame: During hospital admission, an average of 8 days

    The length of stay in hospital after heart valve surgery

  5. Number of participants required chest tube drainage

    Time frame: During hospital admission, an average of 8 days

    The amount of drainage from chest tube after heart valve surgery

  6. Number of participants required re-operation for bleeding

    Time frame: During hospital admission, an average of 8 days

    Re-operation due to excessive bleeding after heart valve surgery

  7. Number of participants died in one month

    Time frame: One month after surgery

    Any cause of death within one month after heart valve surgery

  8. Changes in hemoglobin concentration

    Time frame: Up to 48 hours after heart valve surgery

    Changes in hemoglobin after heart valve surgery

  9. Changes in hematocrit concentration

    Time frame: Up to 48 hours after heart valve surgery

    Changes in hematocrit after heart valve surgery

  10. Changes in serum lactate concentration

    Time frame: Up to 48 hours after heart valve surgery

    Changes in serum lactate after heart valve surgery

  11. Changes in serum blood sugar concentration

    Time frame: Up to 48 hours after heart valve surgery

    Changes in serum blood sugar after heart valve surgery

  12. Number of participants with acute kidney injury

    Time frame: Up to 48 hours after heart valve surgery

    The development of acute kidney injury after heart valve surgery

  13. Changes in liver enzyme concentration

    Time frame: Up to 48 hours after heart valve surgery

    Changes in liver enzyme after heart valve surgery

  14. Amount of cerebral hemispheres' oxygenation

    Time frame: During cardiopulmonary bypass time

    The amount of cerebral oxygenation measured by INVOS in both hemispheres

  15. Changes in coagulation parameters

    Time frame: Up to 48 hours after heart valve surgery

    Changes in coagulation parameters after heart valve surgery

Sponsors and collaborators

Lead sponsor

Rajaie Cardiovascular Medical and Research Center

Other

Collaborators

  • Heart Valve Disease Research Center

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Feb 3, 2022
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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