Changes in Plasma Osmolality Related to the Use of Cardiopulmonary Bypass With Hyperosmolar Prime.

Completed

• Conditions: Cardiopulmonary Bypass
• Interventions: Other: Blood sampling

• Registration Number: NCT03060824
• Lead Sponsor: Umeå University

Brief Summary

During the use of Cardiopulmonary Bypass (CPB) for cardiac surgery there is an instant mixture of the patient's blood and the fluid needed to fill the extracorporeal circuit before use. This will change the composition of the body fluids. This study aims to plot these changes in regard to particle concentration (osmolality).

Detailed Description

During the use of CPB for cardiac surgery there is an instant mixture of the patient's blood and the fluid needed to prime the extracorporeal circuit. Many studies have pointed to the benefits of using a hyperosmolar prime to counteract formation of tissue oedema. Rapid changes in osmolality may as a serious consequence lead to osmotic demyelination syndrome. At the Heart Centre of Umeå University Hospital, Sweden, there is a tradition of using a hyperosmolar prime. This study aims to explore changes in osmolality during coronary artery bypass grafting surgery by repeated measurements of osmolality and concentration shifts of sodium, glucose and urea in plasma.

Study Timeline

• Study First Submitted: 2017-02-17
• Study First Submitted QC: 2017-02-17
• Study Start: 2017-02-21
• Study First Posted: 2017-02-23
• Status Verified: 2017-03
• Primary Completion: 2017-12-11
• Study Completion: 2017-12-11
• Last Update Submitted: 2017-12-14
• Last Update Posted: 2017-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Age 60-80 yr
• New York Heart Association Functional Classification(NYHA) I-III
• Body Surface Area(BSA) 1.8-2.5 m2

Exclusion Criteria

• Diabetes
• Estimated Glomerular Filtration Rate(eGFR)<50ml/min/1,73 m2

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CABG with the aid of CPB.	Blood sampling	Cardiac surgical patients subjected to coronary artery bypass grafting with the aid of Cardiopulmonary Bypass. Perioperative measurements of osmolality in plasma.

Primary Outcome Measures

Name	Time	Method
Changes in plasma osmolality	Before surgery; repeated during surgery and on postoperative day 1 and 2.	Repeated measurements of plasma osmolality aim to outline changes in plasma osmolality related to the use of hyperosmolar prime.

Secondary Outcome Measures

Name	Time	Method
Change in osmolar gap	Before surgery; repeated during surgery and on postoperative day 1 and 2.	Analysing urea, sodium and glucose in plasma using the same sampling intervals as for plasma osmolality enables calculation of the osmolar gap and to set its relation to the use of hyperosmolar prime

Trial Locations

Locations (1)

Heart Centre, Umeå University Hospital; 🇸🇪 Umeå, Sweden