Hyperosmolality and Acute Kidney Injury After Cardiac Surgery

Umeå University

Status: Completed

Conditions: Osmolality Disturbance; Acute Kidney Injury; Cardiopulmonary Bypass

Treatments: Drug: HighOsmo

Study type: Interventional

Funder types: Other

Identifiers

NCT05914896

UmeaU-OSM

Details and patient eligibility

About

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.

Full 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).

Enrollment: 200 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups

NormOsmo

No Intervention group

Description:

This group received a priming solution with normal osmolality.

HighOsmo

Active Comparator group

Description:

This group received a priming solution with high osmolality

Treatment:

Drug: HighOsmo