Skip to main content
OpenTrials
Completed

NCT Number: NCT03060824

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiopulmonary Bypass Cardiovascular Diseases

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Heart Centre, Umeå University Hospital

Umeå, SE 901 85, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 23, 2017
Registry last updated
Dec 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.