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

NCT04665349 | Completed

• 1 other identifier: NKBBN/126/2014
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Dehydration; Perioperative Complication

Outcome Measures

Primary Outcomes (2)

• Amount of total body water

  Measurements will be done with Fresenius Body Composition Monitor

  Changes form baseline after 10 hours of fasting and after 2 hours of pre-op administration

• Extracellular to intracellular water ratio

  Measurements will be done with Fresenius Body Composition Monitor

  Changes form baseline after 10 hours of fasting and after 2 hours of pre-op administration

Study Arms (2)

Pre-op

EXPERIMENTAL

Nutricia Pre-op, 400 milliliters, per os

Dietary Supplement: Nutricia Pre-op, 400 milliliters, per os

Control

NO INTERVENTION

No intervention

Interventions

Nutricia Pre-op, 400 milliliters, per os DIETARY_SUPPLEMENT

After 10 hours of fasting participants will receive per os 400 milliliters of Nutricia Pre-op

Pre-op

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiology (ASA) general condition assessment 1 or 2

You may not qualify if:

• Chronic kidney disease
• Circulatory failure
• Phenylketonuria
• History of hypoglycaemic episodes or any carbohydrate metabolism disorders.

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Medical University of Gdansk - Departament of Anesthesiology and Intensive Care

Gdansk, Pomeranian Voivodeship, 80-210, Poland

Location

Related Publications (1)

• 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.

  PMID: 34372928 DERIVED

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Radosław Owczuk, Professor

  Medical University of Gdansk

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Head of Department of Anaesthesiology and Intensive Care

Study Record Dates

• First Submitted: December 6, 2020
• First Posted: December 11, 2020
• Study Start: November 20, 2019
• Primary Completion: October 12, 2020
• Study Completion: October 13, 2020
• Last Updated: December 11, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)