Effect of Fasting on the Non-invasive Measurement of the Body's Water Compartments
Primary Purpose
Dehydration, Perioperative Complication
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Nutricia Pre-op, 400 milliliters, per os
Sponsored by
About this trial
This is an interventional prevention trial for Dehydration
Eligibility Criteria
Inclusion Criteria:
- American Society of Anesthesiology (ASA) general condition assessment 1 or 2
Exclusion Criteria:
- Chronic kidney disease
- Circulatory failure
- Phenylketonuria
- History of hypoglycaemic episodes or any carbohydrate metabolism disorders.
Sites / Locations
- Medical University of Gdansk - Departament of Anesthesiology and Intensive Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pre-op
Control
Arm Description
Nutricia Pre-op, 400 milliliters, per os
No intervention
Outcomes
Primary Outcome Measures
Amount of total body water
Measurements will be done with Fresenius Body Composition Monitor
Extracellular to intracellular water ratio
Measurements will be done with Fresenius Body Composition Monitor
Secondary Outcome Measures
Full Information
NCT ID
NCT04665349
First Posted
December 6, 2020
Last Updated
December 10, 2020
Sponsor
Medical University of Gdansk
1. Study Identification
Unique Protocol Identification Number
NCT04665349
Brief Title
Effect of Fasting on the Non-invasive Measurement of the Body's Water Compartments
Official Title
Effect of Fasting on the Non-invasive Measurement of the Body's Water Compartments
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
November 20, 2019 (Actual)
Primary Completion Date
October 12, 2020 (Actual)
Study Completion Date
October 13, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Gdansk
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Preoperative fasting is defined as refraining from food for at least 6 hours and clear fluids for at least 2 hours prior to anaesthesia. On the one hand, it is a procedure that reduces the risk of aspiration of food content and the occurrence of Mendelson's syndrome, and on the other hand, it was considered to be the cause of disturbances in water management in patients undergoing general anaesthesia. However, reports from recent years have found that moderate preoperative fasting does not influence the risk of hypovolemia in anesthetized patients. It is also known that in fasting people the total body water is reduced. Thus, it can be assumed that there are mechanisms causing the movement of extravascular water into the lumen of blood vessels. For several years, the Body Composition Monitor (BCM) device for non-invasive measurement of the volume of individual water compartments of the human body has been available on the market. It allows to determine the volume of total body water, intracellular body water and extracellular body water. It is mainly used during dialysis, but it can also be used in other circumstances that require the determination of the body's hydration status. The principle of this method is based on non-invasive bioimpedance measurement with the use of 4 electrodes placed on two extremities.
The aim of the study is to determine whether there is a fluid shift between the intracellular and extracellular compartments in people undergoing preoperative fasting. Examination of this issue would allow for the development of hypothesis regarding the optimal perioperative fluid therapy. If there was a shift of fluid from the intracellular space, it seems more rational to supplement fluid deficiencies resulting from starvation with a 5% glucose solution. If, on the other hand, no fluid shift from the intracellular space was detected, which would suggest shifts within the extracellular space, it would be advisable to hydrate the patient with crystalloid solutions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydration, Perioperative Complication
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pre-op
Arm Type
Experimental
Arm Description
Nutricia Pre-op, 400 milliliters, per os
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutricia Pre-op, 400 milliliters, per os
Intervention Description
After 10 hours of fasting participants will receive per os 400 milliliters of Nutricia Pre-op
Primary Outcome Measure Information:
Title
Amount of total body water
Description
Measurements will be done with Fresenius Body Composition Monitor
Time Frame
Changes form baseline after 10 hours of fasting and after 2 hours of pre-op administration
Title
Extracellular to intracellular water ratio
Description
Measurements will be done with Fresenius Body Composition Monitor
Time Frame
Changes form baseline after 10 hours of fasting and after 2 hours of pre-op administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesiology (ASA) general condition assessment 1 or 2
Exclusion Criteria:
Chronic kidney disease
Circulatory failure
Phenylketonuria
History of hypoglycaemic episodes or any carbohydrate metabolism disorders.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Radosław Owczuk, Professor
Organizational Affiliation
Medical University of Gdansk
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Gdansk - Departament of Anesthesiology and Intensive Care
City
Gdańsk
State/Province
Pomorskie
ZIP/Postal Code
80-210
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34372928
Citation
Kuklinski J, Steckiewicz KP, Sekula B, Aszkielowicz A, Owczuk R. The influence of fasting and carbohydrate-enriched drink administration on body water amount and distribution: a volunteer randomized study. Perioper Med (Lond). 2021 Aug 10;10(1):27. doi: 10.1186/s13741-021-00198-0.
Results Reference
derived
Learn more about this trial
Effect of Fasting on the Non-invasive Measurement of the Body's Water Compartments
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