Cardiac SurgeryPrimeNCT03302286
Effects of Extra Corporeal Circuit Prime on Electrolytes Balance and Clinical Outcome Following Cardiac Surgery
A study testing Heart-lung machine primining solution which includes Mannitol and Heart-lung machine primining solution which does not include Mannitol in people with Cardiac Surgery, run by Region Skane at 1 site in Sweden.
Trial summary
About 6000 heart operations are performed in Sweden every year. A heart-lung machine is used almost exclusively in all heart operations. This machine fills the role of heart and lungs during surgery while the heart is stopped. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Heart-lung machine primining solution which includes Mannitol and Heart-lung machine primining solution which does not include Mannitol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2017to 1 Oct 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients of both sexes who will undergo elective isolated coronary artery bypass grafting at the Department of Cardiothoracic Surgery, Skåne University Hospital, Lund
Who cannot join
- heart failure with left ventricular ejection fraction below 50%
- small size (defined as bodyweight less than 50 kg)
- anaemia with haematocrit less than 24%
- patients with previous cardiac surgery
- patients who receive other fluids or more than 1000 ml additional Ringers's Acetate during cardiopulmonary bypass
- patients with peroperative complications including massive peroperative fluid transfusions
Trial locations and contacts
1 site in 1 country.
About this study
About 6000 heart operations are performed in Sweden every year. A heart-lung machine is used almost exclusively in all heart operations. This machine fills the role of heart and lungs during surgery while the heart is stopped. The extra corporeal circuit (ECC) prime results in hemodilution, as assessed from the decrease in haematocrit, electrolyte concentration and total protein content. This hemodilution is an unavoidable consequence of the use of a heart-lung machine with nonblood ECC prime. The alteration of the patient´s blood volume and electrolytes is affected by the prime solution and can be maintained within normal limits. There are no clear recommendation regarding prime components and numerous prime solutions are in use worldwide.
The aim of this study is to investigate whether the use of mannitol in heart-lung machine prime has an effect on electrolytes levels and osmolality when compared with patients who receive no Mannitol.
- Conditions
- Cardiac Surgery
- Being tested
- Heart-lung machine primining solution which includes Mannitol, Heart-lung machine primining solution which does not include Mannitol
- Keywords
- Heart-Lung Machine, Cardiopulmonary Bypass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart-lung machine primining solution which includes MannitolDiagnostic test
This study group will undergo cardiopulmonary bypass with priming solution of Ringer's acetate 1000 ml, Mannitol 200 ml, Heparin 10000 units and 80 mmol sodium.
Heart-lung machine primining solution which does not include MannitolDiagnostic test
This study group will undergo cardiopulmonary bypass with priming solution of Ringer's acetate 1200 ml, Heparin 10000 units and 80 mmol sodium.
| Study group | Role | What they receive |
|---|---|---|
| Mannitol Prime | Active comparator | This group will undergo cardiac surgery with heart-lung machine with priming solution of Ringer's acetate 1000 ml, Mannitol 200 ml, Heparin 10000 units and 80 mmol sodium. Receives: Diagnostic Test: Heart-lung machine primining solution which includes Mannitol |
| NonMannitol Prime | Active comparator | This group will receive a priming solution of Ringer´s acetate 1200 ml, Heparin 10000 units and 80 mmol sodium. Receives: Diagnostic Test: Heart-lung machine primining solution which does not include Mannitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
osmolality
This study uses blood samples that are taken at predefined timepoints.
Measured: Measurements will be taken three minutes after administration of cardioplegia during cardiopulmonary bapass.
Secondary outcomes (1)
urine outcome
Production of urine will be studed following cardiac operation
Measured: Measurements will be taken during first 24 hours following cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start1 Oct 2017
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
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 Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Snejana Hyllén, Region Skane
- Investigators
- Snejana Hyllen, phd, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302286
- Sponsor's protocol ID
- 2017/422
- Acronym
- Prime
- Status last verified
- Jan 2022
- First submitted
- 25 Sep 2017
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Skold A, Dardashti A, Lindstedt S, Hyllen S. No benefit of adding mannitol to cardiopulmonary bypass priming solution assessing cystatin C. A randomized clinical trial. Perfusion. 2026 Mar;41(2):155-164. doi: 10.1177/02676591251344857. Epub 2025 May 24.
PubMed 40411794
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Extra Corporeal Circuit Prime on Electrolytes Balance and Clinical Outcome Following Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03302286
- Acronym / sponsor ID
- Prime / 2017/422
- Conditions
- Cardiac Surgery
- Keywords
- Heart-Lung Machine, Cardiopulmonary Bypass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 5 Oct 2017 (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.
About 6000 heart operations are performed in Sweden every year. A heart-lung machine is used almost exclusively in all heart operations. This machine fills the role of heart and lungs during surgery while the heart is stopped. The extra corporeal circuit (ECC) prime results in hemodilution, as assessed from the decrease in haematocrit, electrolyte concentration and total protein content. This hemodilution is an unavoidable consequence of the use of a heart-lung machine with nonblood ECC prime. The alteration of the patient´s blood volume and electrolytes is affected by the prime solution and can be maintained within normal limits. There are no clear recommendation regarding prime components and numerous prime solutions are in use worldwide.
The aim of this study is to investigate whether the use of mannitol in heart-lung machine prime has an effect on electrolytes levels and osmolality when compared with patients who receive no Mannitol.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mannitol Prime | Active comparator | Diagnostic Test: Heart-lung machine primining solution which includes MannitolThis group will undergo cardiac surgery with heart-lung machine with priming solution of Ringer's acetate 1000 ml, Mannitol 200 ml, Heparin 10000 units and 80 mmol sodium. |
| NonMannitol Prime | Active comparator | Diagnostic Test: Heart-lung machine primining solution which does not include MannitolThis group will receive a priming solution of Ringer´s acetate 1200 ml, Heparin 10000 units and 80 mmol sodium. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients of both sexes who will undergo elective isolated coronary artery bypass grafting at the Department of Cardiothoracic Surgery, Skåne University Hospital, Lund
Key exclusion criteria (6 listed)
- heart failure with left ventricular ejection fraction below 50%
- small size (defined as bodyweight less than 50 kg)
- anaemia with haematocrit less than 24%
- patients with previous cardiac surgery
- patients who receive other fluids or more than 1000 ml additional Ringers's Acetate during cardiopulmonary bypass
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 |
|---|---|---|
| Heart-lung machine primining solution which includes MannitolThis study group will undergo cardiopulmonary bypass with priming solution of Ringer's acetate 1000 ml, Mannitol 200 ml, Heparin 10000 units and 80 mmol sodium. | Diagnostic test | Mannitol Prime |
| Heart-lung machine primining solution which does not include MannitolThis study group will undergo cardiopulmonary bypass with priming solution of Ringer's acetate 1200 ml, Heparin 10000 units and 80 mmol sodium. | Diagnostic test | NonMannitol Prime |
Primary outcome
osmolality
Time frame: Measurements will be taken three minutes after administration of cardioplegia during cardiopulmonary bapass.
This study uses blood samples that are taken at predefined timepoints.
1 secondary outcome
urine outcome
Time frame: Measurements will be taken during first 24 hours following cardiac surgery
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 18 Jan 2022.
- Derived from this study: PubMed 40411794Skold A, Dardashti A, Lindstedt S, Hyllen S. No benefit of adding mannitol to cardiopulmonary bypass priming solution assessing cystatin C. A randomized clinical trial. Perfusion. 2026 Mar;41(2):155-164. doi: 10.1177/02676591251344857. Epub 2025 May 24.
- Individual participant dataSharing planned: No
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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.
Snejana Hyllen, phd principal investigator
Region Skane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart-lung machine primining solution which includes Mannitol and Heart-lung machine primining solution which does not include Mannitol in people with Cardiac Surgery, run by Region Skane 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 6 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 18 Jan 2022. 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?
osmolality (time frame: Measurements will be taken three minutes after administration of cardioplegia during cardiopulmonary bapass.). 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 NCT03302286, 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 18 Jan 2022.