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

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 Overview

• Status: Completed
• Conditions: Cardiac Surgery
• Intervention / Treatment: Diagnostic test: Heart-lung machine primining solution which includes Mannitol; Diagnostic test: Heart-lung machine primining solution which does not include Mannitol

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Skane
    • Lund, Skane, Sweden, 22185
      • Thorax

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mannitol Prime; 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; 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.
Active Comparator: NonMannitol Prime; 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; This study group will undergo cardiopulmonary bypass with priming solution of Ringer's acetate 1200 ml, Heparin 10000 units and 80 mmol sodium.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
urine outcome	Production of urine will be studed following cardiac operation	Measurements will be taken during first 24 hours following cardiac surgery

Collaborators and Investigators

• Sponsor: Region Skane
• Investigators: Principal Investigator: Snejana Hyllen, phd, Region Skane

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: September 25, 2017
• First Submitted That Met QC Criteria: October 3, 2017
• First Posted (Actual): October 5, 2017

Study Record Updates

• Last Update Posted (Actual): January 18, 2022
• Last Update Submitted That Met QC Criteria: January 14, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Cardiopulmonary Bypass; Heart-Lung Machine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Natriuretic Agents; Diuretics, Osmotic; Diuretics; Mannitol; Pharmaceutical Solutions
• Other Study ID Numbers: 2017/422

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No