NCT04972500

The Influence of Fasting on Selected Hemodynamic Parameters Measured in a Non-invasive Way

Completed NA Last updated 8 November 2021

What this trial tests

NA trial testing Nutricia Pre-op, 400 milliliters, per os in Perioperative Complication in 100 participants. Completed in 4 November 2021.

Timeline

12 July 2021

Primary endpoint
4 November 2021

4 November 2021

Quick facts

Lead sponsor	Medical University of Gdansk
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	100
Start date	12 July 2021
Primary completion	4 November 2021
Estimated completion	4 November 2021
Sites	1 location across Poland

Drugs / interventions tested

• Nutricia Pre-op, 400 milliliters, per os

Conditions studied

• Perioperative Complication — all drugs for Perioperative Complication →
• Hemodynamic Instability — all drugs for Hemodynamic Instability →

Sponsor

Medical University of Gdansk

Who can join

Adults 18 to 40, any sex, with Perioperative Complication or Hemodynamic Instability. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Preoperative fasting is considered to be refraining from taking meals for at least 6 hours and clear fluids for at least 2 hours before anesthesia. On the one hand, it is a procedure that reduces the risk of aspiration of chyme and the occurrence of Mendelson's syndrome, and on the other hand, it is one of the causes of water and carbohydrate disturbances in patients undergoing general anesthesia. Most of them experience some degree of dehydration in the preoperative period. It is associated with a worse prognosis. Due to the negative impact of fasting on homeostasis, as well as significant changes in heart rate in participants in the previous study, we decided to measure the hemodynamic parameters during fasting. The development of impedance cardiography techniques enables the measurement of these parameters by a non-invasive method.

After obtaining the participant's written consent to participate in the study, the first measurement of body weight, blood pressure using a non-invasive method and hemodynamic parameters using a non-invasive impedance cardiography method using the Niccomo ™ device (Medizinische Messtechnik GmbH) will be performed in the evening. The subject will then be asked to refrain from food for at least 10 hours and fluid for 6 hours before the next measurement. The next morning, another measurement will be made and the participant will be randomly assigned to one of two groups: subjects in the first group will be asked to refrain from eating and drinking for another 2 hours, while subjects in the second group per os will receive 400 milliliters of PreOp® (Nutricia ™ preparation intended for preoperative dietary management in surgical patients, containing carbohydrates and electrolytes). After another two hours, the third measurement of the tested parameters will be performed. The obtained results will be subjected to statistical analysis consisting in comparing the values of hemodynamic parameters between the studied groups at appropriate measurement points.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of Carbohydrate-Enriched Drink Compared to Fasting on Hemodynamics in Healthy Volunteers. A Randomized Trial.
   Kukliński J, Steckiewicz KP, Piwowarczyk SP, Kreczko MJ, et al · · 2022 · cited 3× · PMID 35160276 · DOI 10.3390/jcm11030825