Effect of Fasting on the Non-invasive Measurement of the Body's Water Compartments

• ClinicalTrials.gov Identifier: NCT04665349
• Recruitment Status: Completed
• First Posted: December 11, 2020
• Last Update Posted: December 11, 2020
• Sponsor: Medical University of Gdansk
• Information provided by (Responsible Party): Radosław Owczuk, Medical University of Gdansk

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.

Condition or disease	Intervention/treatment	Phase
Dehydration; Perioperative Complication	Dietary Supplement: Nutricia Pre-op, 400 milliliters, per os	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 81 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Effect of Fasting on the Non-invasive Measurement of the Body's Water Compartments
• Actual Study Start Date: November 20, 2019
• Actual Primary Completion Date: October 12, 2020
• Actual Study Completion Date: October 13, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Pre-op; Nutricia Pre-op, 400 milliliters, per os	Dietary Supplement: Nutricia Pre-op, 400 milliliters, per os; After 10 hours of fasting participants will receive per os 400 milliliters of Nutricia Pre-op
No Intervention: Control; No intervention

Outcome Measures

Primary Outcome Measures :

1. Amount of total body water [ Time Frame: Changes form baseline after 10 hours of fasting and after 2 hours of pre-op administration ]
   Measurements will be done with Fresenius Body Composition Monitor
2. Extracellular to intracellular water ratio [ Time Frame: Changes form baseline after 10 hours of fasting and after 2 hours of pre-op administration ]
   Measurements will be done with Fresenius Body Composition Monitor

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Poland

Medical University of Gdansk - Departament of Anesthesiology and Intensive Care

Gdańsk, Pomorskie, Poland, 80-210

Sponsors and Collaborators

Medical University of Gdansk

Investigators

• Principal Investigator: Radosław Owczuk, Professor; Medical University of Gdansk

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kukliński J, Steckiewicz KP, Sekuła B, Aszkiełowicz 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.

• Responsible Party: Radosław Owczuk, Clinical Professor, Head of Department of Anaesthesiology and Intensive Care, Medical University of Gdansk
• ClinicalTrials.gov Identifier: NCT04665349
• Other Study ID Numbers: NKBBN/126/2014
• First Posted: December 11, 2020
• Last Update Posted: December 11, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Additional relevant MeSH terms:

Dehydration; Water-Electrolyte Imbalance; Metabolic Diseases; Pathologic Processes