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

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ClinicalTrials.gov Identifier: NCT03060824
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Cardiopulmonary Bypass Other: Blood sampling

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.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Changes in Plasma Osmolality Related to the Use of Cardiopulmonary Bypass With Hyperosmolar Prime, an Observational Study.
Actual Study Start Date : February 21, 2017
Actual Primary Completion Date : December 11, 2017
Actual Study Completion Date : December 11, 2017

Group/Cohort Intervention/treatment
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
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.




Primary Outcome Measures :
  1. Changes in plasma osmolality [ Time Frame: 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 :
  1. Change in osmolar gap [ Time Frame: 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



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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients subjected to coronary artery bypass grafting with the aid of Cardiopulmonary Bypass.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03060824


Locations
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Sweden
Heart Centre, Umeå University Hospital
Umeå, Sweden, SE 901 85
Sponsors and Collaborators
Umeå University
Investigators
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Principal Investigator: Magnus Hedström, MD Heart Centre, Umeå University Hospital, Sweden

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Umeå University
ClinicalTrials.gov Identifier: NCT03060824     History of Changes
Other Study ID Numbers: 2016/509-31
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data will be shared after reviewing final results after study completion at this site and through publication in a scientific journal.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Umeå University:
Osmolality
Sodium
CABG
Cardiovascular Diseases
Cardiopulmonary bypass