Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05914896
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2023-06-07
Brief Title:
Hyperosmolality and Acute Kidney Injury After Cardiac Surgery
Sponsor:
Umeå University
Organization:
Umeå University
Study Overview
Official Title:
Hyperosmolar Priming Solution for Cardiopulmonary Bypass May Increase the Risk for Postoperative Acute Kidney Injury Results From Double-blinded Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this randomized controlled trial is to test if a hyperosmolar prime solution used for cardiopulmonary bypass increases the risk for acute postoperative kidney injury
Detailed Description:
Two-hundred cardiac surgical patients were randomised into two groups based on the osmolality level of the prime solution used for cardiopulmonary bypass The high osmolality group 966 mOsm received a prime solution containing Ringer-Acetate 1000 ml Mannitol 400 ml 60 g Sodium-Chloride 40 ml 160 mmol and Heparin 2 ml 10 000 IU while the reference group with normal osmolality 388 mOsm received a prime solution containing Ringer-Acetate 1400 ml and Heparin 2 ml 10 000 IU
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None