Hyperosmolality and Acute Kidney Injury After Cardiac Surgery

• Sponsor: Umeå University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05914896
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Actual Duration (Months): 14
• Patients Per Site Per Month: 14.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury; Osmolality Disturbance; Cardiopulmonary Bypass	Drug: HighOsmo	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomisation into two groups based on the osmolality level in the priming solution used for cardiopulmonary bypass.Randomisation into two groups based on the osmolality level in the priming solution used for cardiopulmonary bypass.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Priming of the heart-lung machine performed by a staff member not affiliated to the study protocol.
• Primary Purpose: Prevention
• Official Title: Hyperosmolar Priming Solution for Cardiopulmonary Bypass May Increase the Risk for Postoperative Acute Kidney Injury: Results From Double-blinded Randomised Controlled Trial
• Actual Study Start Date: Apr 24, 2019
• Actual Primary Completion Date: Jun 24, 2020
• Actual Study Completion Date: Jun 24, 2020

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: NormOsmo This group received a priming solution with normal osmolality.
Active Comparator: HighOsmo This group received a priming solution with high osmolality	Drug: HighOsmo; This group received a priming solution with high osmolality

Outcome Measures

Primary Outcome Measures

1. Postoperative Acute Kidney Injury [Three days]

   Defined according to the KDIGO definition

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Public Health Clinical Medicine Umeå University	Umeå	Vasterbotten	Sweden	SE 901 85

Sponsors and Collaborators

• Umeå University

Investigators

• Principal Investigator: Staffan Svenmarker, PhD, Public Health & Clinical Medicine Umeå University, Sweden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Umeå University
• ClinicalTrials.gov Identifier: NCT05914896
• Other Study ID Numbers: UmeaU-OSM
• First Posted: Jun 22, 2023
• Last Update Posted: Jun 22, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Umeå University: Cardiopulmonary Bypass; Priming Solution; Plasma Osmolality; Acute Kidney Injury
• Additional relevant MeSH terms: Acute Kidney Injury; Wounds and Injuries

Study Results

No Results Posted as of Jun 22, 2023