NCT05914896

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 24, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2020

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
Last Updated

June 22, 2023

Status Verified

May 1, 2023

Enrollment Period

1.2 years

First QC Date

June 7, 2023

Last Update Submit

June 19, 2023

Conditions

Acute Kidney InjuryOsmolality DisturbanceCardiopulmonary Bypass

Keywords

Cardiopulmonary BypassPriming SolutionPlasma OsmolalityAcute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • Postoperative Acute Kidney Injury

    Defined according to the KDIGO definition

    Three days

Study Arms (2)

NormOsmo

NO INTERVENTION

This group received a priming solution with normal osmolality.

HighOsmo

ACTIVE COMPARATOR

This group received a priming solution with high osmolality

Drug: HighOsmo

Interventions

HighOsmoDRUG

This group received a priming solution with high osmolality

HighOsmo

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patient eligible for routine cardiac surgical procedures requiring cardiopulmonary bypass.

You may not qualify if:

  • Patients requiring acute surgical intervention within 24 h or profound hypothermia during surgery were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Public Health Clinical Medicine Umeå University

Umeå, Västerbotten County, SE 901 85, Sweden

Location

Related Publications (1)

  • Hashimoto H, Yamada H, Murata M, Watanabe N. Diuretics for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2025 Jan 29;1(1):CD014937. doi: 10.1002/14651858.CD014937.pub2.

    PMID: 39878152DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Staffan Svenmarker, PhD

    Public Health & Clinical Medicine Umeå University, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Priming of the heart-lung machine performed by a staff member not affiliated to the study protocol.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomisation into two groups based on the osmolality level in the priming solution used for cardiopulmonary bypass.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2023

First Posted

June 22, 2023

Study Start

April 24, 2019

Primary Completion

June 24, 2020

Study Completion

June 24, 2020

Last Updated

June 22, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Limited by ethical regulations

Locations

SE(1)