Acid Base ImbalancePRIMEIINCT07267546
Heart-Lung Machine: Impact of the Priming Solution on Acid-Base Balance, Electrolytes and Outcome on Patients Undergoing Cardiac Surgery
A study testing Ringer's Acetate 80, Plasmalyte and Ringer's Acetate no add in people with Acid Base Imbalance and Osmolality Disturbance, run by Region Skane at 1 site in Sweden.
Trial summary
Most cardiac surgery procedures requires the use of heart-lung machine. The heart-lung machine circuit needs to be filled with a fluid before connecting it to the patients circulation. This is called priming and is accomplished by filling the circuit with a solution used for fluid replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acid Base Imbalance, Osmolality Disturbance, Crystalloid Solutions
- What is being tested?
- Ringer's Acetate 80, Plasmalyte and Ringer's Acetate no add
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2025to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients 18 years and above
- Undergoing coronary artery bypass graft (CABG) surgery as single surgery
- Undergoing aortic valve replacement (AVR) as single surgery (AtriClip is allowed)
- Given consent to participate, both verbal and written
Who cannot join
- Subnormal heart function (defined as an ejection fraction <45%), and no signs of heart failure (edema).
- Body weight <60 kg or >120 kg
- Preoperative hemoglobin <120 g/L,
- Subnormal kidney function (defined as GFR <30 ml/min),
- Blood sodium outside normal range (135-145 mmol/l),
- Need of acute surgery
- AVR due to aortic valve insufficiency
- Changes in operating method or addition of intraoperative procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Heart-Lung Machine: Impact of the Priming Solution on the Body's Acid-Base Balance, Electrolyte Composition and Clinical Outcome (PRIMEII)
Most cardiac surgery procedures requires the use of heart-lung machine. The heart-lung machine circuit needs to be filled with a fluid before connecting it to the patients circulation. This is called priming and is accomplished by filling the circuit with a solution used for fluid replacement. The circuit in our institution requires 1100 mL to be filled.
The body has several mechanisms with the purpose to maintain its state of balance. When a large amount of clear solution suddenly enters the blood stream this balance can be altered. The goal of this clinical trial is to investigate different priming solutions in the heart-lung machine circuit. The main questions it aims to answer are:
Read more
How do different priming solutions alter the acid-base balance, osmolality and electrolytes which reflects the body's water balance for patients undergoing cardiac surgery with the use of heart-lung machine?
There will be 4 different groups:
- Ringer-Acetate, 1100 mL / no addition
- Ringer-Acetate, 1100 mL + 80 mmol sodium chloride (NaCl)
- Ringer-Acetate, 1100 mL + 160 mmol NaCl
- Plasmalyte, 1100 mL / no addition Blood samples will be taken before, during and after surgery, post operative day 1 and 4 to analyze acid-base balance, electrolytes, and plasma osmolality. Urine output and hydration status will also be collected until post operative day 1. After 3 months, a blood sample will be taken for analysis of electrolytes and kidney function.
Read the detailed description
Cardiopulmonary bypass (CBP) with a heart-lung machine is mandatory for a vast majority of cardiac surgeries. Briefly the disposables in a CPB circuit consists of a reservoir, an oxygenator and tubings.
The role of CPB can be summarized as follows:
- Empty the heart. Drain out the blood (achieved via venous cannulas).
- Oxygenate the blood and remove carbon dioxide. Thus, the lungs are not participating during CPB.
- Maintain homeostasis and adjust chemical and electrolyte blood composition.
- Maintain or adjust the body's temperature via a heat exchanger, which is a part of the heart-lung machine.
- Return oxygenated blood to the patient via arterial cannula.
Heart-lung machine provides even the following:
- Salvage blood loss during surgery via cardiotomy suckers and return it to the patient.
- Prevent distention of the heart during surgery via cardiac vents.
- Deliver cardioplegia which stops the heart, providing myocardial protection and condition to perform cardiac surgery.
- Additional treatments, such as hemofiltration and removing av cytokines.
Before connecting the CPB circuit to the patient's circulation it needs to be deaired. This is achieved by priming, i.e. filling the circuit with a liquid solution. The 2024 EACTS (European Association for Cardio-Thoracic Surgery)/EACTA (European Association of Cardiothoracic Anaesthesiology)/EBCP (European Board of Cardiovascular Perfusin) Guidelines on CPB in adult cardiac surgery point out that despite a wealth of studies, no consensus has been reached on the optimal composition of the priming solution. According to recent surveys, balanced crystalloids are the preferred priming solution, but there are no recommendations of the composition in the solution. The standard prime solution at our institution consists of Ringer Acetate which is a common crystalloid fluid in Sweden used intravenously for fluid and volume loss. Due to its composition, i.e. lower pH and sodium and higher chloride concentrations than the human blood, it is sometimes necessary to add electrolytes and other components to the circuit either in advance or after initiation of CPB. Previous studies have investigated various prime compositions and plasma osmolality. The crystalloid priming fluid used in these studies contained mannitol, which has a high osmolality. A former study from our group showed a significant decrease in blood sodium with a mannitol-containing prime, but no effects on plasma osmolality. Highly osmolar priming solution has further been studied, also containing mannitol, and found a steep rise in plasma osmolality. These studies used priming fluids with an addition of 80 mmol NaCl and 160 mmol NaCl, respectively. Plasmalyte is a newer crystalloid solution with a composition of sodium and chloride more similar to human plasma which could be of advantage. Plasmalyte is used for CPB priming in some cardiac centers. Studies on Plasmalyte as a priming solution have shown less metabolic acidosis compared to Ringer Lactate. However, it has not been used in our institution for this purpose and there are no studies comparing Plasmalyte with Ringer Acetate. The literature search has further not found any studies investigating non-mannitol CPB priming solutions with differing additions of NaCl. There is a need to fill this knowledge gap to proceed in developing of the optimal priming solution, tailored to variouse preexisting diseases or conditions.
Scientific questions The overall aim of the project is to investigate if clinical outcome after cardiac surgery can be improved by optimizing the priming solution.
The sub-projects will answer the questions:
- Do the different priming solutions: Ringer Acetate alone, Ringer Acetate with added NaCl and Plasmalyte alone affect the acid-base balance and composition of electrolytes in the blood?
- Do the different priming solutions affect the need to correct the acid-base balance during the heart-lung machine period?
- Do the different priming solutions affect the total fluid balance in connection with cardiac surgery?
- Do the different priming solutions affect the osmolality in the blood per- and postoperatively?
- Do the different priming solutions affect postoperative renal function? Do the different priming solutions affect neurological outcome?
- Conditions
- Acid Base Imbalance, Osmolality Disturbance, Crystalloid Solutions, Electrolyte Changes, Cardiopulmonary Bypass
- Being tested
- Ringer's Acetate 80, Plasmalyte, Ringer's Acetate no add, Ringer's Acetate 160
- Keywords
- cardiopulmonary bypass, priming solution, acid base balance, electrolytes, plasma osmolality
- Medical subject headings
- Acid-Base Imbalance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ringer's Acetate 80Diagnostic test
Cardiopulmonary bypass circuit will be primed with Ringer's Acetate 1100 ml and 80 mmol NaCl
PlasmalyteDiagnostic test
Cardiopulmonary bypass circuit will be primed with Plasmalyte 1100 ml, no addition.
Ringer's Acetate no addDiagnostic test
Cardiopulmonary bypass circuit will be primed with Ringer's Acetate 1100 ml no addition
Ringer's Acetate 160Diagnostic test
Cardiopulmonary bypass circuit will be primed with Ringer's Acetate 1100 ml and 160 mmol NaCl
| Study group | Role | What they receive |
|---|---|---|
| Ringer's Acetate 80 | Active comparator | Ringer's Acetate 1100 ml with addition of 80 mmol NaCl Receives: Diagnostic Test: Ringer's Acetate 80 |
| Plasmalyte | Active comparator | Plasmalyte 1100 ml, no addition Receives: Diagnostic Test: Plasmalyte |
| Ringer's Acetate no add | Active comparator | Ringer's Acetate 1100 ml, no addition Receives: Diagnostic Test: Ringer's Acetate no add |
| Ringer's Acetate 160 | Active comparator | Ringer's Acetate with addition of 160 mmol NaCl Receives: Diagnostic Test: Ringer's Acetate 160 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acid Base Balance
This study uses blood samples that are taken at predefined timepoints
Measured: Measurements will be taken at anesthesia induction, 3 minutes after administration of cardioplegia, 30 minutes after onset of CPB, 5 minutes after termination of CPB, 1 hour post operative, day 1 and day 4 post operative.
Sodium concentration
This study uses blood samples that are taken at predefined timepoints
Measured: Measurements will be taken at anesthesia induction, 3 minutes after administration of cardioplegia, 30 minutes after onset of CPB, 5 minutes after termination of CPB, 1 hour post operative, day 1 and day 4 post operative, and at month 3.
Osmolality
This study uses blood samples that are taken at predefined timepoints
Measured: Measurements will be taken at anesthesia induction, 3 minutes after administration of cardioplegia, 30 minutes after onset of CPB, 15 minutes after termination of CPB, 1 hour post operative, day 1 and day 4 post operative
Secondary outcomes (4)
Chloride, magnesium -and potassium concentrations
This study uses blood samples that are taken at predefined timepoints
Measured: Measurements will be taken at anesthesia induction, 3 minutes after administration of cardioplegia, 30 minutes after onset of CPB, 5 minutes after termination of CPB, 1 hour post operative, day 1 and day 4 post operative, and at month 3.
Urine output
Production of urine will be studied during cardiac operation and post operative
Measured: Measurements of urine output will be registered during cardiac surgery and 24 hours post operative.
Kidney function
Creatinine-and urea concentration, glomerular filtration rate
Measured: Blood samples will be collected pre operative - the day before surgery or in morning the same day, 1 hour post operative, day 1 and day 4 post operative, and at month 3.
Neurological outcome
S-100, a prognostic biomarker used for assessing brain injury
Measured: Blood samples will be collected at anesthesia induction, 1 hour post operative, day 1 and day 4 post operative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 Sep 2025
- Primary completion20 Sep 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acid Base ImbalanceStudies 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
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Snejana Hyllén, Phd,MD, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267546
- Sponsor's protocol ID
- 2025-02925-01-749040
- Other IDs
- 2025
- Acronym
- PRIMEII
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized participant data can be made available on request.
Publications
Surabhi S, Kumar M. Comparison of ringer's lactate and plasmalyt-a as cardiopulmonary bypass prime for bypass associated acidosis in valve replacement surgeries. Ann Card Anaesth. 2021 Jan-Mar;24(1):36-41. doi: 10.4103/aca.ACA_104_19.
PubMed 33938829Ljunggren M, Skold A, Dardashti A, Hyllen S. The use of mannitol in cardiopulmonary bypass prime solution-Prospective randomized double-blind clinical trial. Acta Anaesthesiol Scand. 2019 Nov;63(10):1298-1305. doi: 10.1111/aas.13445. Epub 2019 Jul 29.
PubMed 31287556Malmqvist G, Claesson Lingehall H, Appelblad M, Svenmarker S. Cardiopulmonary bypass prime composition: beyond crystalloids versus colloids. Perfusion. 2019 Mar;34(2):130-135. doi: 10.1177/0267659118793249. Epub 2018 Aug 16.
PubMed 30114960Wahba A, Kunst G, De Somer F, Agerup Kildahl H, Milne B, Kjellberg G, Bauer A, Beyersdorf F, Berg Ravn H, Debeuckelaere G, Erdoes G, Haumann RG, Gudbjartsson T, Merkle F, Pacini D, Paternoster G, Onorati F, Ranucci M, Ristic N, Vives M, Milojevic M; EACTS/EACTAIC/EBCP Scientific Document Group. 2024 EACTS/EACTAIC/EBCP Guidelines on cardiopulmonary bypass in adult cardiac surgery. Eur J Cardiothorac Surg. 2025 Feb 4;67(2):ezae354. doi: 10.1093/ejcts/ezae354. No abstract available.
PubMed 39949326
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart-Lung Machine: Impact of the Priming Solution on the Body's Acid-Base Balance, Electrolyte Composition and Clinical Outcome (PRIMEII)
- ClinicalTrials.gov ID
- NCT07267546
- Acronym / sponsor ID
- PRIMEII / 2025-02925-01-749040
- Conditions
- Acid Base Imbalance, Osmolality Disturbance, Crystalloid Solutions, Electrolyte Changes, Cardiopulmonary Bypass
- Keywords
- cardiopulmonary bypass, priming solution, acid base balance, electrolytes, plasma osmolality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 5 Dec 2025 (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.
Most cardiac surgery procedures requires the use of heart-lung machine. The heart-lung machine circuit needs to be filled with a fluid before connecting it to the patients circulation. This is called priming and is accomplished by filling the circuit with a solution used for fluid replacement. The circuit in our institution requires 1100 mL to be filled.
The body has several mechanisms with the purpose to maintain its state of balance. When a large amount of clear solution suddenly enters the blood stream this balance can be altered. The goal of this clinical trial is to investigate different priming solutions in the heart-lung machine circuit. The main questions it aims to answer are:
How do different priming solutions alter the acid-base balance, osmolality and electrolytes which reflects the body's water balance for patients undergoing cardiac surgery with the use of heart-lung machine?
There will be 4 different groups:
- Ringer-Acetate, 1100 mL / no addition
- Ringer-Acetate, 1100 mL + 80 mmol sodium chloride (NaCl)
- Ringer-Acetate, 1100 mL + 160 mmol NaCl
- Plasmalyte, 1100 mL / no addition Blood samples will be taken before, during and after surgery, post operative day 1 and 4 to analyze acid-base balance, electrolytes, and plasma osmolality. Urine output and hydration status will also be collected until post operative day 1. After 3 months, a blood sample will be taken for analysis of electrolytes and kidney function.
Detailed description
Cardiopulmonary bypass (CBP) with a heart-lung machine is mandatory for a vast majority of cardiac surgeries. Briefly the disposables in a CPB circuit consists of a reservoir, an oxygenator and tubings.
The role of CPB can be summarized as follows:
- Empty the heart. Drain out the blood (achieved via venous cannulas).
- Oxygenate the blood and remove carbon dioxide. Thus, the lungs are not participating during CPB.
- Maintain homeostasis and adjust chemical and electrolyte blood composition.
- Maintain or adjust the body's temperature via a heat exchanger, which is a part of the heart-lung machine.
- Return oxygenated blood to the patient via arterial cannula.
Heart-lung machine provides even the following:
- Salvage blood loss during surgery via cardiotomy suckers and return it to the patient.
- Prevent distention of the heart during surgery via cardiac vents.
- Deliver cardioplegia which stops the heart, providing myocardial protection and condition to perform cardiac surgery.
- Additional treatments, such as hemofiltration and removing av cytokines.
Before connecting the CPB circuit to the patient's circulation it needs to be deaired. This is achieved by priming, i.e. filling the circuit with a liquid solution. The 2024 EACTS (European Association for Cardio-Thoracic Surgery)/EACTA (European Association of Cardiothoracic Anaesthesiology)/EBCP (European Board of Cardiovascular Perfusin) Guidelines on CPB in adult cardiac surgery point out that despite a wealth of studies, no consensus has been reached on the optimal composition of the priming solution. According to recent surveys, balanced crystalloids are the preferred priming solution, but there are no recommendations of the composition in the solution. The standard prime solution at our institution consists of Ringer Acetate which is a common crystalloid fluid in Sweden used intravenously for fluid and volume loss. Due to its composition, i.e. lower pH and sodium and higher chloride concentrations than the human blood, it is sometimes necessary to add electrolytes and other components to the circuit either in advance or after initiation of CPB. Previous studies have investigated various prime compositions and plasma osmolality. The crystalloid priming fluid used in these studies contained mannitol, which has a high osmolality. A former study from our group showed a significant decrease in blood sodium with a mannitol-containing prime, but no effects on plasma osmolality. Highly osmolar priming solution has further been studied, also containing mannitol, and found a steep rise in plasma osmolality. These studies used priming fluids with an addition of 80 mmol NaCl and 160 mmol NaCl, respectively. Plasmalyte is a newer crystalloid solution with a composition of sodium and chloride more similar to human plasma which could be of advantage. Plasmalyte is used for CPB priming in some cardiac centers. Studies on Plasmalyte as a priming solution have shown less metabolic acidosis compared to Ringer Lactate. However, it has not been used in our institution for this purpose and there are no studies comparing Plasmalyte with Ringer Acetate. The literature search has further not found any studies investigating non-mannitol CPB priming solutions with differing additions of NaCl. There is a need to fill this knowledge gap to proceed in developing of the optimal priming solution, tailored to variouse preexisting diseases or conditions.
Scientific questions The overall aim of the project is to investigate if clinical outcome after cardiac surgery can be improved by optimizing the priming solution.
The sub-projects will answer the questions:
- Do the different priming solutions: Ringer Acetate alone, Ringer Acetate with added NaCl and Plasmalyte alone affect the acid-base balance and composition of electrolytes in the blood?
- Do the different priming solutions affect the need to correct the acid-base balance during the heart-lung machine period?
- Do the different priming solutions affect the total fluid balance in connection with cardiac surgery?
- Do the different priming solutions affect the osmolality in the blood per- and postoperatively?
- Do the different priming solutions affect postoperative renal function? Do the different priming solutions affect neurological outcome?
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ringer's Acetate 80 | Active comparator | Diagnostic Test: Ringer's Acetate 80Ringer's Acetate 1100 ml with addition of 80 mmol NaCl |
| Plasmalyte | Active comparator | Diagnostic Test: PlasmalytePlasmalyte 1100 ml, no addition |
| Ringer's Acetate no add | Active comparator | Diagnostic Test: Ringer's Acetate no addRinger's Acetate 1100 ml, no addition |
| Ringer's Acetate 160 | Active comparator | Diagnostic Test: Ringer's Acetate 160Ringer's Acetate with addition of 160 mmol NaCl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 18 years and above
- Undergoing coronary artery bypass graft (CABG) surgery as single surgery
- Undergoing aortic valve replacement (AVR) as single surgery (AtriClip is allowed)
- Given consent to participate, both verbal and written
Key exclusion criteria (8 listed)
- Subnormal heart function (defined as an ejection fraction <45%), and no signs of heart failure (edema).
- Body weight <60 kg or >120 kg
- Preoperative hemoglobin <120 g/L,
- Subnormal kidney function (defined as GFR <30 ml/min),
- Blood sodium outside normal range (135-145 mmol/l),
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 |
|---|---|---|
| Ringer's Acetate 80Cardiopulmonary bypass circuit will be primed with Ringer's Acetate 1100 ml and 80 mmol NaCl | Diagnostic test | Ringer's Acetate 80 |
| PlasmalyteCardiopulmonary bypass circuit will be primed with Plasmalyte 1100 ml, no addition. | Diagnostic test | Plasmalyte |
| Ringer's Acetate no addCardiopulmonary bypass circuit will be primed with Ringer's Acetate 1100 ml no addition | Diagnostic test | Ringer's Acetate no add |
| Ringer's Acetate 160Cardiopulmonary bypass circuit will be primed with Ringer's Acetate 1100 ml and 160 mmol NaCl | Diagnostic test | Ringer's Acetate 160 |
Primary outcome
Acid Base Balance
Time frame: Measurements will be taken at anesthesia induction, 3 minutes after administration of cardioplegia, 30 minutes after onset of CPB, 5 minutes after termination of CPB, 1 hour post operative, day 1 and day 4 post operative.
This study uses blood samples that are taken at predefined timepoints
Sodium concentration
Time frame: Measurements will be taken at anesthesia induction, 3 minutes after administration of cardioplegia, 30 minutes after onset of CPB, 5 minutes after termination of CPB, 1 hour post operative, day 1 and day 4 post operative, and at month 3.
This study uses blood samples that are taken at predefined timepoints
Osmolality
Time frame: Measurements will be taken at anesthesia induction, 3 minutes after administration of cardioplegia, 30 minutes after onset of CPB, 15 minutes after termination of CPB, 1 hour post operative, day 1 and day 4 post operative
This study uses blood samples that are taken at predefined timepoints
4 secondary outcomes
Chloride, magnesium -and potassium concentrations
Time frame: Measurements will be taken at anesthesia induction, 3 minutes after administration of cardioplegia, 30 minutes after onset of CPB, 5 minutes after termination of CPB, 1 hour post operative, day 1 and day 4 post operative, and at month 3.
Urine output
Time frame: Measurements of urine output will be registered during cardiac surgery and 24 hours post operative.
Kidney function
Time frame: Blood samples will be collected pre operative - the day before surgery or in morning the same day, 1 hour post operative, day 1 and day 4 post operative, and at month 3.
Neurological outcome
Time frame: Blood samples will be collected at anesthesia induction, 1 hour post operative, day 1 and day 4 post operative.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Background: PubMed 33938829Surabhi S, Kumar M. Comparison of ringer's lactate and plasmalyt-a as cardiopulmonary bypass prime for bypass associated acidosis in valve replacement surgeries. Ann Card Anaesth. 2021 Jan-Mar;24(1):36-41. doi: 10.4103/aca.ACA_104_19.
- Background: PubMed 31287556Ljunggren M, Skold A, Dardashti A, Hyllen S. The use of mannitol in cardiopulmonary bypass prime solution-Prospective randomized double-blind clinical trial. Acta Anaesthesiol Scand. 2019 Nov;63(10):1298-1305. doi: 10.1111/aas.13445. Epub 2019 Jul 29.
- Background: PubMed 30114960Malmqvist G, Claesson Lingehall H, Appelblad M, Svenmarker S. Cardiopulmonary bypass prime composition: beyond crystalloids versus colloids. Perfusion. 2019 Mar;34(2):130-135. doi: 10.1177/0267659118793249. Epub 2018 Aug 16.
- Background: PubMed 39949326Wahba A, Kunst G, De Somer F, Agerup Kildahl H, Milne B, Kjellberg G, Bauer A, Beyersdorf F, Berg Ravn H, Debeuckelaere G, Erdoes G, Haumann RG, Gudbjartsson T, Merkle F, Pacini D, Paternoster G, Onorati F, Ranucci M, Ristic N, Vives M, Milojevic M; EACTS/EACTAIC/EBCP Scientific Document Group. 2024 EACTS/EACTAIC/EBCP Guidelines on cardiopulmonary bypass in adult cardiac surgery. Eur J Cardiothorac Surg. 2025 Feb 4;67(2):ezae354. doi: 10.1093/ejcts/ezae354. No abstract available.
- Individual participant dataSharing planned: Yes. Anonymized participant data can be made available on request.
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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.
Snejana Hyllén, Phd,MD 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 Ringer's Acetate 80, Plasmalyte and Ringer's Acetate no add in people with Acid Base Imbalance and Osmolality Disturbance, 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 5 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Snejana Hyllén, PhD (+46 763131231, snejana.hyllen@skane.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acid Base Balance (time frame: Measurements will be taken at anesthesia induction, 3 minutes after administration of cardioplegia, 30 minutes after onset of CPB, 5 minutes after termination of CPB, 1 hour post operative, day 1 and day 4 post operative.). The study lists 3 primary outcomes in all. 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 NCT07267546, which also lists 4 linked publications.
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 5 Dec 2025.