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Hyperosmolality and Acute Kidney Injury After Cardiac Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05914896
Enrollment
200
Registered
2023-06-22
Start date
2019-04-24
Completion date
2020-06-24
Last updated
2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Cardiopulmonary Bypass, Osmolality Disturbance

Keywords

Cardiopulmonary Bypass, Priming Solution, Plasma Osmolality, Acute Kidney Injury

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.

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).

Interventions

DRUGHighOsmo

This group received a priming solution with high osmolality

Sponsors

Umeå University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Priming of the heart-lung machine performed by a staff member not affiliated to the study protocol.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Acute Kidney InjuryThree daysDefined according to the KDIGO definition

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026