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NCT05914896 Clinical Trial

Hyperosmolality and Acute Kidney Injury After Cardiac Surgery

Acute Kidney Injury Clinical Trial

Official title:
Hyperosmolar Priming Solution for Cardiopulmonary Bypass May Increase the Risk for Postoperative Acute Kidney Injury: Results From Double-blinded Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05914896
Other study ID # UmeaU-OSM
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 24, 2019
Est. completion date June 24, 2020

Study information
Verified date May 2023
Source Umeå University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date June 24, 2020
Est. primary completion date June 24, 2020
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Patient eligible for routine cardiac surgical procedures requiring cardiopulmonary bypass. Exclusion Criteria: - Patients requiring acute surgical intervention within 24 h or profound hypothermia during surgery were excluded.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• HighOsmo
This group received a priming solution with high osmolality

Locations
Country Name City State
Sweden Department of Public Health Clinical Medicine Umeå University Umeå Vasterbotten

Sponsors (1)
Lead Sponsor Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative Acute Kidney Injury Defined according to the KDIGO definition Three days
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