drugset / Trial / NCT05223361
Cardiopulmonary Bypass Prime Solution in Patients Undergoing Heart Valve Surgery
Phase 3
Completed
120 enrolled
Rajaie Cardiovascular Medical and Research Center
Heart Valve Disease Research Center · collab
RandomizedParallel-groupTriple-blindPrevention
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.
Timeline
- Start
- 2016-04
- Primary completion
- 2021-04-30
- Completion
- 2021-11-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ringer lactate | Other / unclassified | 1000 ml | — |
| Comparator | Ringer lactate | Other / unclassified | 1500 ml | — |
| Comparator | Six percent hydroxy ethyl starch 130/0.4 | Unknown | 6 % | — |
| Comparator | Six percent hydroxy ethyl starch 130/0.4 | Unknown | 500 ml | — |