Skip to main content
OpenTrials
Completed

NCT Number: NCT02906514

Priming of Cardiopulmonary Bypass With Hydroxyethyl Starch 130/0.4 or Sodium Chloride 0.9% : Pilot Study in Adult Elective Conventional Cardiac Surgery

Best priming for cardiopulmonary bypass in cardiac surgery is unknown. Efficacy and toxicity of Hydroxyethyl Starch 130/0.4 used in this context are uncertain.

The aim of this pilot study is to determine if Hydroxyethyl Starch 130/0.4 is more effective than Sodium Chloride 0.9% in short term hemodynamic purpose without side renal or hemostatic effect.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Extracorporeal Circulation Cardiac Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospices Civils de Lyon - Hopital Louis Pradel

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients scheduled for elective conventional cardiac surgery with cardiopulmonary bypass
  • Patients insured under the French social security system

Exclusion criteria

  • Pregnancy
  • Patients placed under guardianship
  • Urgent surgery
  • Cardiac surgery without cardiopulmonary bypass
  • Anterior cardiac surgery
  • Non conventional cardiac surgery (mini-invasive surgery, dual valve replacement, right heart surgery)
  • Simultaneous inclusion in another study with potential interference in outcomes
  • Heparin-induced thrombocytopenia
  • Chronic renal insufficiency (glomerular filtration rate < 60mL.min-1.m-2)
  • Nature/nurture hemostasis disorders, in particular Von Willebrand disease and hemophilia
  • Hydroxyethyl Starch allergy
  • Weight under 33 kg
  • Mechanical hemodynamic support at the end of the surgery

Treatment and study plan

Non balanced Hydroxyethyl starch 130/0.4 (Voluven®, Fresenius)

Drug

1000mL used for cardiopulmonary bypass priming

Sodium Chloride 0.9% (Fresenius)

Drug

1000mL used for cardiopulmonary bypass priming

Primary outcomes

  1. Supplementary volume of fluid administered during cardiopulmonary bypass (ml)

    Time frame: Day 1 (From initiation to separation of cardiopulmonary bypass)

    Fluid administered during cardiopulmonary bypass for normal functioning, with the exception of blood product, cardioplegia and priming

Secondary outcomes

  1. Variation of preoperative hematocrit and lowest hematocrit during cardiopulmonary bypass

    Time frame: Day 1 (From initiation to separation of cardiopulmonary bypass)

    Continuous monitoring of hematocrit during cardiopulmonary bypass.

  2. Fluid balance

    Time frame: Hour 0

    Difference between total intraoperative volume of fluids administered (vascular filling, blood products, cardioplegia, priming) and total intraoperative volume of fluids loss (urine, bleedings)

  3. Fluid balance

    Time frame: Hour 12

    Difference between total intraoperative volume of fluids administered (vascular filling, blood products, cardioplegia, priming) and total intraoperative volume of fluids loss (urine, bleedings)

  4. Sequential Organ Failure Assessment score

    Time frame: Hour 24

  5. Sequential Organ Failure Assessment score

    Time frame: Hour 0

  6. Acid-Base parameters : arterial pH

    Time frame: Hour 24

  7. Acid-Base parameters : Base Excess

    Time frame: Hour 0

  8. Acid-Base parameters : Base Excess

    Time frame: H24

  9. Acid-Base parameters : Lactatemia

    Time frame: Hour 0

  10. Acid-Base parameters : Lactatemia

    Time frame: Hour 24

  11. Acid-Base parameters : Chloremia

    Time frame: Hour 0

  12. Acid-Base parameters : Chloremia

    Time frame: Hour 24

  13. Coagulation parameters : platelets

    Time frame: Hour 0

  14. Coagulation parameters : prothrombin

    Time frame: Hour 0

  15. Coagulation parameters : activated partial thromboplastin

    Time frame: Hour 0

  16. Coagulation parameters : fibrinogen level

    Time frame: Hour 0

  17. Coagulation parameters : platelets

    Time frame: H24

  18. Coagulation parameters : prothrombin

    Time frame: H24

  19. Coagulation parameters : activated partial thromboplastin

    Time frame: H24

  20. Coagulation parameters : fibrinogen level

    Time frame: H24

  21. Hemoglobin level

    Time frame: Hour 0

  22. Hemoglobin level

    Time frame: Hour 24

  23. Surgical bleeding

    Time frame: Hour 12

  24. Surgical bleeding

    Time frame: during surgical drainage, an average of 24 hours

  25. Revision surgery for bleeding

    Time frame: Hour 12

  26. Delay for ablation of surgical drainage

    Time frame: Day of ablation of surgical drainage, 24 hours

  27. Antiemetic medication use

    Time frame: end of intensive care unit stay, 24 hours

    Any antiemetic medication used during this period

  28. Delay to first extubation (number of hours)

    Time frame: Hour of first extubation, an average of 5 hours

  29. Intensive care unit stay (number oh days)

    Time frame: Day of intensive care unit stay exit

  30. Hospital stay (number of days)

    Time frame: Day of hospital exit, an average of 7 days

  31. Creatinine level variation

    Time frame: Day 5

  32. Creatinine level variation

    Time frame: Day 28

  33. Creatinine level variation

    Time frame: Day 90

  34. Renal replacement therapy use during intensive care stay

    Time frame: end of intensive care unit stay, an average of 24 hours

  35. Renal replacement therapy dependency

    Time frame: Day 28

  36. Renal replacement therapy dependency

    Time frame: Day 90

  37. Mortality of any cause

    Time frame: During hospital stay, an average of 7 days

  38. Mortality of any cause

    Time frame: Day 28

  39. Mortality of any cause

    Time frame: Day 90

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Priming of Cardiopulmonary Bypass With Hydroxyethyl Starch 130/0.4 or Sodium Chloride 0.9% : a Double Blind Randomized Pilot Study in Adult Elective Conventional Cardiac Surgery

Acronym: OPTIMUS-PRIME

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 20, 2016
Registry last updated
Aug 6, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.