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

December 14, 2017 updated by: Umeå University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Umeå, Sweden, SE 901 85
        • Heart Centre, Umeå University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before surgery; repeated during surgery and on postoperative day 1 and 2.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Before surgery; repeated during surgery and on postoperative day 1 and 2.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Investigators

  • Principal Investigator: Magnus Hedström, MD, Heart Centre, Umeå University Hospital, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2017

Primary Completion (Actual)

December 11, 2017

Study Completion (Actual)

December 11, 2017

Study Registration Dates

First Submitted

February 17, 2017

First Submitted That Met QC Criteria

February 17, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

December 15, 2017

Last Update Submitted That Met QC Criteria

December 14, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2016/509-31

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data will be shared after reviewing final results after study completion at this site and through publication in a scientific journal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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