Hyperosmolality and Acute Kidney Injury After Cardiac Sur... | NCT05914896

Studies
Hyperosmolality and Acute Kidney Injury After Cardiac Surgery

NCT05914896

Sponsor

Umeå University

Status

Completed

Last Update Posted

Jun 22, 2023Actual

Enrollment

200Actual

Phase

Not Applicable

Conditions

Acute Kidney Injury
Osmolality Disturbance
Cardiopulmonary Bypass

Interventions

HighOsmo

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 24, 2019Actual

Primary Completion Date

Jun 24, 2020Actual

Completion Date

Jun 24, 2020Actual

First Submitted Date

Jun 7, 2023

First Submission Date that Met QC Criteria

Jun 19, 2023

First Posted Date

Jun 22, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2023

Last Update Posted Date

Jun 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
HighOsmo	Drug	This group received a priming solution with high osmolality	HighOsmo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative Acute Kidney Injury	Defined according to the KDIGO definition	Three days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Staffan Svenmarker, PhD	Public Health & Clinical Medicine Umeå University, Sweden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Public Health Clinical Medicine Umeå University		Umeå	Västerbotten County	SE 901 85	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39878152	Derived	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.

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases