Clinical trial NCT03060824: Changes in Plasma Osmolality Related to the Use of Cardiopulmonary Bypass With Hyperosmolar Prime.
Official title: Changes in Plasma Osmolality Related to the Use of Cardiopulmonary Bypass With Hyperosmolar Prime, an Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiopulmonary Bypass
Keywords: Osmolality
Sodium
CABG
Cardiovascular Diseases
Cardiopulmonary bypass
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients subjected to coronary artery bypass grafting with the aid of Cardiopulmonary Bypass.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in plasma osmolality
timeFrame: Before surgery; repeated during surgery and on postoperative day 1 and 2.
Secondary outcomes:
measure: Change in osmolar gap
timeFrame: Before surgery; repeated during surgery and on postoperative day 1 and 2.
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Heart Centre, Umeå University Hospital
Study officials:
affiliation: Heart Centre, Umeå University Hospital, Sweden
name: Magnus Hedström, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Giuliani C, Peri A. Effects of Hyponatremia on the Brain. J Clin Med. 2014 Oct 28;3(4):1163-77. doi: 10.3390/jcm3041163.
citation: Malmqvist G, Claesson Lingehall H, Appelblad M, Svenmarker S. Cardiopulmonary bypass prime composition: beyond crystalloids versus colloids. Perfusion. 2019 Mar;34(2):130-135. doi: 10.1177/0267659118793249. Epub 2018 Aug 16.
citation: Drury NE, Horsburgh A, Bi R, Willetts RG, Jones TJ. Cardioplegia practice in paediatric cardiac surgery: a UK & Ireland survey. Perfusion. 2019 Mar;34(2):125-129. doi: 10.1177/0267659118794343. Epub 2018 Aug 10.