Hyperosmolality and Acute Kidney Injury After Cardiac Surgery

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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Key information

Conditions

Acute Kidney Injury Cardiopulmonary Bypass Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Osmolality Disturbance Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Public Health Clinical Medicine Umeå University

Umeå, Västerbotten County, SE 901 85, Sweden

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HighOsmo

Drug

This group received a priming solution with high osmolality

Primary outcomes

Postoperative Acute Kidney Injury

Time frame: Three days

Defined according to the KDIGO definition

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Jun 22, 2023
Registry last updated: Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed