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

NCT ID: NCT04665349

Last Updated: 2020-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-20

Study Completion Date

2020-10-13

Brief Summary

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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.

Detailed Description

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Conditions

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Dehydration Perioperative Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Pre-op

Nutricia Pre-op, 400 milliliters, per os

Group Type EXPERIMENTAL

Nutricia Pre-op, 400 milliliters, per os

Intervention Type DIETARY_SUPPLEMENT

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

Control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nutricia Pre-op, 400 milliliters, per os

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Gdansk

OTHER

Sponsor Role lead

Responsible Party

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Radosław Owczuk

Clinical Professor, Head of Department of Anaesthesiology and Intensive Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Radosław Owczuk, Professor

Role: PRINCIPAL_INVESTIGATOR

Medical University of Gdansk

Locations

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Medical University of Gdansk - Departament of Anesthesiology and Intensive Care

Gdansk, Pomeranian Voivodeship, Poland

Site Status

Countries

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Poland

References

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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.

Reference Type DERIVED
PMID: 34372928 (View on PubMed)

Other Identifiers

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NKBBN/126/2014

Identifier Type: -

Identifier Source: org_study_id