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

NCT03060824 | Completed

• 1 other identifier: 2016/509-31
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Cardiopulmonary Bypass

Keywords

Osmolality; Sodium; CABG; Cardiovascular Diseases; Cardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in osmolar gap

  Before surgery; repeated during surgery and on postoperative day 1 and 2.

Study Arms (1)

CABG with the aid of CPB.

Cardiac surgical patients subjected to coronary artery bypass grafting with the aid of Cardiopulmonary Bypass. Perioperative measurements of osmolality in plasma.

Other: Blood sampling

Interventions

Blood sampling OTHER

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.

CABG with the aid of CPB.

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients subjected to coronary artery bypass grafting with the aid of Cardiopulmonary Bypass.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Heart Centre, Umeå University Hospital

Umeå, SE 901 85, Sweden

Location

Related Publications (4)

• 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.

  PMID: 24415398 BACKGROUND

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

  PMID: 26237597 BACKGROUND

• 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.

  PMID: 30114960 DERIVED

• 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.

  PMID: 30095360 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Magnus Hedström, MD

  Heart Centre, Umeå University Hospital, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2017
• First Posted: February 23, 2017
• Study Start: February 21, 2017
• Primary Completion: December 11, 2017
• Study Completion: December 11, 2017
• Last Updated: December 15, 2017

Record last verified: 2017-03

Locations

SE (1)