Acute Kidney InjuryNCT05914896
Hyperosmolality and Acute Kidney Injury After Cardiac Surgery
A study testing HighOsmo in people with Acute Kidney Injury and Osmolality Disturbance, run by Umeå University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Acute Kidney Injury, Osmolality Disturbance, Cardiopulmonary Bypass
- What is being tested?
- HighOsmo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 24 Apr 2019to 24 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient eligible for routine cardiac surgical procedures requiring cardiopulmonary bypass.
Who cannot join
- Patients requiring acute surgical intervention within 24 h or profound hypothermia during surgery were excluded.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Public Health Clinical Medicine Umeå University
Umeå, Västerbotten County, SE 901 85
About this study
Official title: Hyperosmolar Priming Solution for Cardiopulmonary Bypass May Increase the Risk for Postoperative Acute Kidney Injury: Results From Double-blinded Randomised Controlled Trial
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.
Read the 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).
- Being tested
- HighOsmo
- Keywords
- Cardiopulmonary Bypass, Priming Solution, Plasma Osmolality, Acute Kidney Injury
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HighOsmoDrug
This group received a priming solution with high osmolality
| Study group | Role | What they receive |
|---|---|---|
| NormOsmo | No intervention | This group received a priming solution with normal osmolality. |
| HighOsmo | Active comparator | This group received a priming solution with high osmolality Receives: Drug: HighOsmo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Acute Kidney Injury
Defined according to the KDIGO definition
Measured: Three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start24 Apr 2019
- Primary completion24 Jun 2020
- Study completion24 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomisation into two groups based on the osmolality level in the priming solution used for cardiopulmonary bypass.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Staffan Svenmarker, PhD, Principal investigator, Public Health & Clinical Medicine Umeå University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914896
- Sponsor's protocol ID
- UmeaU-OSM
- Status last verified
- May 2023
- First submitted
- 7 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Limited by ethical regulations
Publications
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.
PubMed 39878152
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperosmolar Priming Solution for Cardiopulmonary Bypass May Increase the Risk for Postoperative Acute Kidney Injury: Results From Double-blinded Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05914896
- Acronym / sponsor ID
- UmeaU-OSM
- Keywords
- Cardiopulmonary Bypass, Priming Solution, Plasma Osmolality, Acute Kidney Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- 24 Jun 2020 (actual)
- Study completion
- 24 Jun 2020 (actual)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomisation into two groups based on the osmolality level in the priming solution used for cardiopulmonary bypass.
| Arm | Type | Receives |
|---|---|---|
| NormOsmo | No intervention | –This group received a priming solution with normal osmolality. |
| HighOsmo | Active comparator | Drug: HighOsmoThis group received a priming solution with high osmolality |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patient eligible for routine cardiac surgical procedures requiring cardiopulmonary bypass.
Key exclusion criteria (1 listed)
- Patients requiring acute surgical intervention within 24 h or profound hypothermia during surgery were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HighOsmoThis group received a priming solution with high osmolality | Drug | HighOsmo |
Primary outcome
Postoperative Acute Kidney Injury
Time frame: Three days
Defined according to the KDIGO definition
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Derived from this study: PubMed 39878152Hashimoto 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.
- Individual participant dataSharing planned: No. Limited by ethical regulations
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
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Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
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Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Staffan Svenmarker, PhD principal investigator
Public Health & Clinical Medicine Umeå University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HighOsmo in people with Acute Kidney Injury and Osmolality Disturbance, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Acute Kidney Injury (time frame: Three days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05914896, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.