Perioperative ComplicationNCT04972500
The Influence of Fasting on Selected Hemodynamic Parameters Measured in a Non-invasive Way
A study testing Nutricia Pre-op, 400 milliliters, per os in people with Perioperative Complication and Hemodynamic Instability, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Perioperative Complication, Hemodynamic Instability
- What is being tested?
- Nutricia Pre-op, 400 milliliters, per os
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 12 Jul 2021to 4 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- American Society of Anesthesiology (ASA) general condition assessment 1 or 2
Who cannot join
- Chronic kidney disease
- Circulatory failure
- Lung diseases
- Diseases of the heart valves
- History of hypoglycaemic episodes or any carbohydrate disturbance.
- Height less than 120 cm or greater than 230 cm
- Body weight less than 30 kg or greater than 155 kg.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Medical University of Gdansk - Departament of Anesthesiology and Intensive Care
Gdansk, Pomeranian Voivodeship, 80-210
About this study
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.
- Being tested
- Nutricia Pre-op, 400 milliliters, per os
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutricia Pre-op, 400 milliliters, per osDietary supplement
After 10 hours of fasting participants will receive per os 400 milliliters of Nutricia Pre-op
| Study group | Role | What they receive |
|---|---|---|
| Pre-op | Experimental | Nutricia Pre-op, 400 milliliters, per os Receives: Dietary Supplement: Nutricia Pre-op, 400 milliliters, per os |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cardiac index (CI)
Cardiac index will be measured non-invasively with Niccomo™(Medizinische Messtechnik GmbH) device.
Cardiac index will be measured in l/min/m^2 (liters per minute per square meter).
Measured: Changes form baseline after 10 hours of fasting and after 2 hours of pre-op administration
Changes in systemic vascular resistance index (SVRI)
Systemic vascular resistance index will be measured non-invasively with Niccomo™(Medizinische Messtechnik GmbH) device.
Systemic vascular resistance index will be measured in dyn*s*cm^-5*m^2 (dyne multiply by second multiply by centimeters to the power of minus 5 multiply by square meter)
Measured: Changes form baseline after 10 hours of fasting and after 2 hours of pre-op administration
Changes in stroke volume (SV)
Stroke volume will be measured non-invasively with Niccomo™(Medizinische Messtechnik GmbH) device.
Stroke volume will be measured in mL (milliliters).
Measured: Changes form baseline after 10 hours of fasting and after 2 hours of pre-op administration
Changes in heart rate (HR)
Heart rate will be measured non-invasively with Niccomo™(Medizinische Messtechnik GmbH) device.
Heart rate will be measured in 1/min (beats per minute).
Measured: Changes form baseline after 10 hours of fasting and after 2 hours of pre-op administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start12 Jul 2021
- Primary completion4 Nov 2021
- Study completion4 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative ComplicationStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radosław Owczuk, Medical University of Gdansk
- Investigators
- Radoslaw Owczuk, Prof., Principal investigator, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972500
- Sponsor's protocol ID
- PREOP2
- Status last verified
- Nov 2021
- First submitted
- 9 Jul 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Fasting on Selected Hemodynamic Parameters Measured in a Non-invasive Way
- ClinicalTrials.gov ID
- NCT04972500
- Acronym / sponsor ID
- PREOP2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 4 Nov 2021 (actual)
- Study completion
- 4 Nov 2021 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-op | Experimental | Dietary Supplement: Nutricia Pre-op, 400 milliliters, per osNutricia Pre-op, 400 milliliters, per os |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiology (ASA) general condition assessment 1 or 2
Key exclusion criteria (7 listed)
- Chronic kidney disease
- Circulatory failure
- Lung diseases
- Diseases of the heart valves
- History of hypoglycaemic episodes or any carbohydrate disturbance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutricia Pre-op, 400 milliliters, per osAfter 10 hours of fasting participants will receive per os 400 milliliters of Nutricia Pre-op | Dietary supplement | Pre-op |
Primary outcome
Changes in cardiac index (CI)
Time frame: Changes form baseline after 10 hours of fasting and after 2 hours of pre-op administration
Cardiac index will be measured non-invasively with Niccomo™(Medizinische Messtechnik GmbH) device. Cardiac index will be measured in l/min/m^2 (liters per minute per square meter).
Changes in systemic vascular resistance index (SVRI)
Time frame: Changes form baseline after 10 hours of fasting and after 2 hours of pre-op administration
Systemic vascular resistance index will be measured non-invasively with Niccomo™(Medizinische Messtechnik GmbH) device. Systemic vascular resistance index will be measured in dyn*s*cm^-5*m^2 (dyne multiply by second multiply by centimeters to the power of minus 5 multiply by square meter)
Changes in stroke volume (SV)
Time frame: Changes form baseline after 10 hours of fasting and after 2 hours of pre-op administration
Stroke volume will be measured non-invasively with Niccomo™(Medizinische Messtechnik GmbH) device. Stroke volume will be measured in mL (milliliters).
Changes in heart rate (HR)
Time frame: Changes form baseline after 10 hours of fasting and after 2 hours of pre-op administration
Heart rate will be measured non-invasively with Niccomo™(Medizinische Messtechnik GmbH) device. Heart rate will be measured in 1/min (beats per minute).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Radoslaw Owczuk, Prof. principal investigator
Medical University of Gdansk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutricia Pre-op, 400 milliliters, per os in people with Perioperative Complication and Hemodynamic Instability, run by Medical University of Gdansk at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cardiac index (CI) (time frame: Changes form baseline after 10 hours of fasting and after 2 hours of pre-op administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.