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

Cardiopulmonary Bypass Clinical Trial

Official title:

Changes in Plasma Osmolality Related to the Use of Cardiopulmonary Bypass With Hyperosmolar Prime, an Observational Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03060824
• Other study ID #: 2016/509-31
• Status: Completed
• Phase: N/A
• First received: February 17, 2017
• Last updated: December 14, 2017
• Start date: February 21, 2017
• Est. completion date: December 11, 2017

Study information

• Verified date: March 2017
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 11, 2017
• Est. primary completion date: December 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiopulmonary Bypass

Intervention

Other:
• Blood sampling
To explore changes in osmolality during coronary artery bypass grafting surgery with the aid of Cardiopulmonary Bypass by repeated measurements of osmolality and concentration shifts of sodium, glucose and urea in plasma.

Locations

Country	Name	City	State
Sweden	Heart Centre, Umeå University Hospital	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

Giuliani C, Peri A. Effects of Hyponatremia on the Brain. J Clin Med. 2014 Oct 28;3(4):1163-77. doi: 10.3390/jcm3041163. Review. — View Citation

Gu YJ, Boonstra PW. Selection of priming solutions for cardiopulmonary bypass in adults. Multimed Man Cardiothorac Surg. 2006 Jan 1;2006(109):mmcts.2005.001198. doi: 10.1510/mmcts.2005.001198. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in plasma osmolality	Repeated measurements of plasma osmolality aim to outline changes in plasma osmolality related to the use of hyperosmolar prime.	Before surgery; repeated during surgery and on postoperative day 1 and 2.
Secondary	Change in osmolar gap	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	Before surgery; repeated during surgery and on postoperative day 1 and 2.