Intraabdominal HypertensionNCT05626868
Changes of Intra Abdominal Pressure During Surgeries in Prone Position as a Marker of Renal Damage
An observational study of Intraabdominal Hypertension and Prone Postion, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Background: Patients undergoing surgical operations in prone position do not have a measure of intra abdominal pressure as a standard procedure. Many of them could have elevated values of this parameter and could be exposed to possible renal damage due to a stiffening of the abdominal muscles while being positioned… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraabdominal Hypertension, Prone Postion, Spine Surgery
- What is being tested?
- Intra abdominal pressure measurement
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 sitePoland
- Study dates
- 1 May 2021to 31 Dec 2022
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients qualified for spinal surgery in prone position, who consent to praticipate in the study.
Who may be able to join
- Consent to participate in the study
- Patients qualified for surgical stabilization of the spine in prone position
Who cannot join
- No consent to participate in the study or inability to obtain consent
- The inability to insert a urinary catheter
- No indication for urinary catheter
- Patients undergoing palliative treatment
- Patients with advanced liver and kidney disease
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Warsaw: 1st Department of Anaesthesiology and Intensive Therapy
Warsaw, Masovian Voivodeship, 02-005
Rafał Kowałczyk, MD, +48 22 5021685, rafal.kowalczyk@wum.edu.pl
About this study
Official title: Intraoperative Abdominal Pressure Measurement in Patients Undergoing Spine Surgeries in Prone Position as a Marker of Renal Damage
Background: Patients undergoing surgical operations in prone position do not have a measure of intra abdominal pressure as a standard procedure. Many of them could have elevated values of this parameter and could be exposed to possible renal damage due to a stiffening of the abdominal muscles while being positioned prone.
Purpose of study: Intraoperative intrabdominal pressure measurement and evaluation of correlation with possible postsurgical complications.
Read more
Methodology: Electronic device able to measure intra abdominal pressure is connected between a Foley catheter and a urinary collecting bag. During the procedure, values of the intra abdominal pressure are displayed on a monitor next to anaesthetic machine in real time. The numbers representing the pressure in mmHG are assessed and recorded.
Discussion: Possible correlation between intra abdominal hypertension and postsurgical complications in patients operated in prone position could be a foundation to further clinical trials and presurgical assessment of intraabdominal pressure.
- Conditions
- Intraabdominal Hypertension, Prone Postion, Spine Surgery
- Being tested
- Intra abdominal pressure measurement
- Medical subject headings
- Intra-Abdominal Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra abdominal pressure measurementDevice
Device: Biometrix - Intraabdominal pressure monitoring set Intraabdominal pressure monitoring with the intended set in values of milimeters of mercury (mmHg) in real time.
| Study group | Role | What they receive |
|---|---|---|
| Patients for spine surgery in prone position | Not described Receives: Device: Intra abdominal pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in intra abdominal pressure during surgery.
Change in intra abdominal pressure during surgery in prone position.
Measured: Intraoperative
Secondary outcomes (4)
Correlation of increased abdominal pressure with renal dysfunction assessed by creatinine.
Assessment of renal function in labolatory tests: creatinine change (mg/dl).
Measured: From start to eight hours after the surgery.
Correlation of increased abdominal pressure with renal dysfunction assessed by urea.
Assessment of renal function in labolatory tests: urea change (mg/dl).
Measured: From start of surgery to eight hours after the surgery.
Correlation of increased abdominal pressure with renal dysfunction assessed by potassium.
Assessment of renal function in labolatory tests: potassium change (mg/dl).
Measured: From start of surgery to eight hours after the surgery.
Correlation of increased abdominal pressure with mioglobin.
Assessment in labolatory tests: mioglobin change (mg/dl).
Measured: From start of surgery to eight hours after the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start1 May 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraabdominal HypertensionStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rafał Kowalczyk, MD, Principal investigator, Medical Unieveristy of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626868
- Sponsor's protocol ID
- MG/M/37/37/20(1)
- Status last verified
- Nov 2022
- First submitted
- 15 Nov 2022
- Last updated
- 25 Nov 2022
- 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 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Abdominal Pressure Measurement in Patients Undergoing Spine Surgeries in Prone Position as a Marker of Renal Damage
- ClinicalTrials.gov ID
- NCT05626868
- Acronym / sponsor ID
- MG/M/37/37/20(1)
- Conditions
- Intraabdominal Hypertension, Prone Postion, Spine Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 25 Nov 2022 (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.
Background: Patients undergoing surgical operations in prone position do not have a measure of intra abdominal pressure as a standard procedure. Many of them could have elevated values of this parameter and could be exposed to possible renal damage due to a stiffening of the abdominal muscles while being positioned prone.
Purpose of study: Intraoperative intrabdominal pressure measurement and evaluation of correlation with possible postsurgical complications.
Methodology: Electronic device able to measure intra abdominal pressure is connected between a Foley catheter and a urinary collecting bag. During the procedure, values of the intra abdominal pressure are displayed on a monitor next to anaesthetic machine in real time. The numbers representing the pressure in mmHG are assessed and recorded.
Discussion: Possible correlation between intra abdominal hypertension and postsurgical complications in patients operated in prone position could be a foundation to further clinical trials and presurgical assessment of intraabdominal pressure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients for spine surgery in prone position | – | Device: Intra abdominal pressure measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients qualified for spinal surgery in prone position, who consent to praticipate in the study.
Key inclusion criteria (2 listed)
- Consent to participate in the study
- Patients qualified for surgical stabilization of the spine in prone position
Key exclusion criteria (5 listed)
- No consent to participate in the study or inability to obtain consent
- The inability to insert a urinary catheter
- No indication for urinary catheter
- Patients undergoing palliative treatment
- Patients with advanced liver and kidney disease
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 |
|---|---|---|
| Intra abdominal pressure measurementDevice: Biometrix - Intraabdominal pressure monitoring set Intraabdominal pressure monitoring with the intended set in values of milimeters of mercury (mmHg) in real time. | Device | Patients for spine surgery in prone position |
Primary outcome
Increase in intra abdominal pressure during surgery.
Time frame: Intraoperative
Change in intra abdominal pressure during surgery in prone position.
4 secondary outcomes
Correlation of increased abdominal pressure with renal dysfunction assessed by creatinine.
Time frame: From start to eight hours after the surgery.
Correlation of increased abdominal pressure with renal dysfunction assessed by urea.
Time frame: From start of surgery to eight hours after the surgery.
Correlation of increased abdominal pressure with renal dysfunction assessed by potassium.
Time frame: From start of surgery to eight hours after the surgery.
Correlation of increased abdominal pressure with mioglobin.
Time frame: From start of surgery to eight hours after the surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2022.
- 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.
Rafał Kowalczyk, MD principal investigator
Medical Unieveristy of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraabdominal Hypertension and Prone Postion, run by Medical University of Warsaw 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 25 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bartosz Stangiewicz, MD (+48605941973, bartosz.stangiewicz@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in intra abdominal pressure during surgery. (time frame: Intraoperative). 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 25 Nov 2022.