Heart-Lung Machine: Impact of the Priming Solution on Acid-Base Balance, Electrolytes and Outcome on Patients Undergoing Cardiac Surgery

NCT07267546 | Recruiting

• 1 other identifier: 2025-02925-01-749040
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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:

1. 1.Ringer-Acetate, 1100 mL / no addition
2. 2.Ringer-Acetate, 1100 mL + 80 mmol sodium chloride (NaCl)
3. 3.Ringer-Acetate, 1100 mL + 160 mmol NaCl
4. 4.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.

Conditions

Acid Base Imbalance; Osmolality Disturbance; Crystalloid Solutions; Electrolyte Changes; Cardiopulmonary Bypass

Keywords

cardiopulmonary bypass; priming solution; acid base balance; electrolytes; plasma osmolality

Outcome Measures

Primary Outcomes (3)

• Acid Base Balance

  This study uses blood samples that are taken at predefined timepoints

  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

  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

  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

  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

  Measurements of urine output will be registered during cardiac surgery and 24 hours post operative.

• Kidney function

  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

  Blood samples will be collected at anesthesia induction, 1 hour post operative, day 1 and day 4 post operative.

Study Arms (4)

Ringer's Acetate 80

ACTIVE COMPARATOR

Ringer's Acetate 1100 ml with addition of 80 mmol NaCl

Diagnostic Test: Ringer's Acetate 80

Plasmalyte

ACTIVE COMPARATOR

Plasmalyte 1100 ml, no addition

Diagnostic Test: Plasmalyte

Ringer's Acetate no add

ACTIVE COMPARATOR

Ringer's Acetate 1100 ml, no addition

Diagnostic Test: Ringer's Acetate no add

Ringer's Acetate 160

ACTIVE COMPARATOR

Ringer's Acetate with addition of 160 mmol NaCl

Diagnostic Test: Ringer's Acetate 160

Interventions

Ringer's Acetate 80 DIAGNOSTIC_TEST

Cardiopulmonary bypass circuit will be primed with Ringer's Acetate 1100 ml and 80 mmol NaCl

Ringer's Acetate 80

Plasmalyte DIAGNOSTIC_TEST

Cardiopulmonary bypass circuit will be primed with Plasmalyte 1100 ml, no addition.

Plasmalyte

Ringer's Acetate no add DIAGNOSTIC_TEST

Cardiopulmonary bypass circuit will be primed with Ringer's Acetate 1100 ml no addition

Ringer's Acetate no add

Ringer's Acetate 160 DIAGNOSTIC_TEST

Cardiopulmonary bypass circuit will be primed with Ringer's Acetate 1100 ml and 160 mmol NaCl

Ringer's Acetate 160

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Skane University hospital

Lund, 22185, Sweden

RECRUITING

Related Publications (4)

• 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.

  PMID: 33938829 BACKGROUND

• Ljunggren 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.

  PMID: 31287556 BACKGROUND

• Malmqvist 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.

  PMID: 30114960 BACKGROUND

• Wahba 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.

  PMID: 39949326 BACKGROUND

MeSH Terms

Conditions

Acid-Base Imbalance

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Snejana Hyllén, Phd,MD

  Region Skane

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Snejana Hyllén, PhD

CONTACT

+46 763131231; snejana.hyllen@skane.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 5, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Anonymized data will be available November 2026 and stored for 10 years.
• Access Criteria: Requests must be from studies with appropriate ethics approval.

Locations

SE (1)