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

Sponsor

Region Skane (Other)

Overall Status

Completed

CT.gov ID

NCT03302286

Collaborator

(none)

110

Enrollment

Location

Arms

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Surgery	Diagnostic Test: Heart-lung machine primining solution which includes Mannitol Diagnostic Test: Heart-lung machine primining solution which does not include Mannitol	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Oct 1, 2017

Actual Primary Completion Date :

Oct 1, 2021

Actual Study Completion Date :

Oct 1, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

osmolality [Measurements will be taken three minutes after administration of cardioplegia during cardiopulmonary bapass.]
This study uses blood samples that are taken at predefined timepoints.

Secondary Outcome Measures

urine outcome [Measurements will be taken during first 24 hours following cardiac surgery]
Production of urine will be studed following cardiac operation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Thorax	Lund	Skane	Sweden	22185

Sponsors and Collaborators

Region Skane

Investigators

Principal Investigator: Snejana Hyllen, phd, Region Skane

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Snejana Hyllén, MD, Region Skane

ClinicalTrials.gov Identifier:

NCT03302286

Other Study ID Numbers:

2017/422

First Posted:

Oct 5, 2017

Last Update Posted:

Jan 18, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Snejana Hyllén, MD, Region Skane

Heart-Lung Machine

Cardiopulmonary Bypass

Additional relevant MeSH terms:

Mannitol

Pharmaceutical Solutions

Study Results

No Results Posted as of Jan 18, 2022