Effects of Extra Corporeal Circuit Prime on Electrolytes Balance and Clinical Outcome Following Cardiac Surgery

NCT03302286 | Completed

• 1 other identifier: 2017/422
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Heart-Lung Machine; Cardiopulmonary Bypass

Outcome Measures

Primary Outcomes (1)

• osmolality

  This study uses blood samples that are taken at predefined timepoints.

  Measurements will be taken three minutes after administration of cardioplegia during cardiopulmonary bapass.

Secondary Outcomes (1)

• urine outcome

  Measurements will be taken during first 24 hours following cardiac surgery

Study Arms (2)

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.

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.

Diagnostic Test: Heart-lung machine primining solution which does not include Mannitol

Interventions

Heart-lung machine primining solution which includes Mannitol DIAGNOSTIC_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.

Mannitol Prime

Heart-lung machine primining solution which does not include Mannitol DIAGNOSTIC_TEST

This study group will undergo cardiopulmonary bypass with priming solution of Ringer's acetate 1200 ml, Heparin 10000 units and 80 mmol sodium.

NonMannitol Prime

Eligibility Criteria

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

You may qualify if:

• adult patients of both sexes who will undergo elective isolated coronary artery bypass grafting at the Department of Cardiothoracic Surgery, Skåne University Hospital, Lund

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Thorax

Lund, Skåne County, 22185, Sweden

Location

Related Publications (1)

• 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. 2025 May 24:2676591251344857. doi: 10.1177/02676591251344857. Online ahead of print.

  PMID: 40411794 DERIVED

Study Officials

• Snejana Hyllen, phd

  Region Skane

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: October 5, 2017
• Study Start: October 1, 2017
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: January 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)