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Hyperosmolality and Acute Kidney Injury After Cardiac Surgery

NCT ID: NCT05914896

Last Updated: 2023-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-24

Study Completion Date

2020-06-24

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Acute Kidney Injury Osmolality Disturbance Cardiopulmonary Bypass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomisation into two groups based on the osmolality level in the priming solution used for cardiopulmonary bypass.
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Priming of the heart-lung machine performed by a staff member not affiliated to the study protocol.

Study Groups

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NormOsmo

This group received a priming solution with normal osmolality.

Group Type NO_INTERVENTION

No interventions assigned to this group

HighOsmo

This group received a priming solution with high osmolality

Group Type ACTIVE_COMPARATOR

HighOsmo

Intervention Type DRUG

This group received a priming solution with high osmolality

Interventions

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HighOsmo

This group received a priming solution with high osmolality

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Umeå University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Staffan Svenmarker, PhD

Role: PRINCIPAL_INVESTIGATOR

Public Health & Clinical Medicine Umeå University, Sweden

Locations

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Department of Public Health Clinical Medicine Umeå University

Umeå, Västerbotten County, Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 39878152 (View on PubMed)

Other Identifiers

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UmeaU-OSM

Identifier Type: -

Identifier Source: org_study_id

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