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

NCT ID: NCT03060824

Last Updated: 2017-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-21

Study Completion Date

2017-12-11

Brief Summary

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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

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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.

Conditions

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Cardiopulmonary Bypass

Keywords

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Osmolality Sodium CABG Cardiovascular Diseases Cardiopulmonary bypass

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Blood sampling

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Umeå University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Magnus Hedström, MD

Role: PRINCIPAL_INVESTIGATOR

Heart Centre, Umeå University Hospital, Sweden

Locations

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Heart Centre, Umeå University Hospital

Umeå, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 24415398 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 26237597 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30114960 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30095360 (View on PubMed)

Other Identifiers

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2016/509-31

Identifier Type: -

Identifier Source: org_study_id