Intracranial Pressure IncreaseNCT03707054
Vasopressin in Intraabdominal Pressure Elevation
A study testing Study Arm in people with Intracranial Pressure Increase and Abdominal Compartment Syndrome, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The aim of this study is to investigate any direct correlation between increased intrathoracic pressure, intraabdominal pressure and intracranial pressure, following a controlled elevation in intraabdominal pressure and intrathoracic pressure (PEEP). Read more about this study
- Who is it for?
- Ages 18 to 72 yearsHealthy volunteers can take part
- Conditions the study is for
- Intracranial Pressure Increase, Abdominal Compartment Syndrome
- What is being tested?
- Study Arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2017to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 72 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-72
- Patients meeting NIH criteria for bariatric surgery
- Patients undergoing laparoscopic sleeve gastrectomy
Who cannot join
- • Age below 18 years
- American Society of Anesthesiologist (ASA) class IV or V
- Other evident/diagnosed causes of increased IAP or increased intrathoracic pressure, except for obesity
- Active urinary tract infection
- Previous or concomitant neurological disease
- Previous or concomitant ophthalmic conditions/eye surgery
- Previous or concomitant lung diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Vasopressin and Renal Function Following a Controlled Intraabdominal Pressure Elevation
The aim of this study is to investigate any direct correlation between increased intrathoracic pressure, intraabdominal pressure and intracranial pressure, following a controlled elevation in intraabdominal pressure and intrathoracic pressure (PEEP). The second end-point is to investigate any correlation between elevated intracranial pressure and vasopressin release, urine output and urine and serum osmolality by measuring their values at different time-points.
Read the detailed description
Increase in intraabdominal pressure (IAP) has been demonstrated to correlate with consequential hemodynamic effects. Several studies have been carried out mostly in experimental settings to define the underlying mechanisms that regulate the pathophysiology following an increase in IAP. In the last years this topic has become concerning because of the wide spread of laparoscopy, that is namely an iatrogenic acute increase in IAP.
Patients selected and consented for elective surgery will undergo standard of care and additional measurements during and after surgery. The measurements will be done at different stages of laparoscopic surgery.
- A) Baseline, patient under general anesthesia, Foley catheter positioned, beginning urine collection, before insufflation of pneumoperitoneum
- B) 10-15 minutes after insufflation of pneumoperitoneum at 15mmHg, PEEP at 5cmH2O or lowest setting
- C) 10-15 minutes after stabilization of PEEP at 10cmH2O, pneumoperitoneum still at 15 mmHg
- D) 10-15 minutes after desufflation of pneumoperitoneum and basal mechanical ventilation
Measurements include :
- Intraabdominal pressure IAP: assessed via laparoscopic insufflator, set at 15 mmHg as a standard value for all laparoscopic procedures
- Intrathoracic pressure: indirectly measured by variability of peak expiratory pressures
- Urine collection: through a Foley catheter from the beginning of surgery to post-operative day 1
- Urine osmolality (to be assessed at set time-points )
- Hourly urine output (at least 24 hours in order to evaluate expected significant variation even after the procedure end, since renal adaptation could take longer period)
- Serum/plasma collection : blood draws to evaluate specific values of
- Plasma Vasopressin (ADH)
- Serum osmolality
- Mean arterial pressure : standard of care
- Pulmonary expiratory end-pressure (PEEP): anesthesiologists routinely adapt PEEP in order to maintain an optimal ventilation, especially in obese patients and during laparoscopy
- Optic nerve sheath diameter (ONSD): a 7.5-MHz linear ultrasound probe to measure the diameter of the optic nerve sheath 3 mm behind the globe is going to be used; a trained study personnel physician will take the non-invasive sonographic picture using ultrasound. The ONSD will be measured from the captured picture. Study personnel will record the interaction on the patient's chart and include the measurement on the database
- Being tested
- Study Arm
- Medical subject headings
- Intracranial Hypertension, Intra-Abdominal Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study ArmDiagnostic test
Measurements of optic nerve diameter, serum and urine osmolarity, serum vasopressin
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Experimental | Measurements of optic nerve diameter, Urine and plasma osmolality, Serum vasopressin. Receives: Diagnostic Test: Study Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Vasopressin Levels During Pneumoperitoneum and Elevated PEEP
The investigators will measure the intrabdominal pressure (IAP) pressure using the laparoscopic insufflator dial, the optic nerve sheath diameter (OSND) using an ultrasound which is a surrogate of the intracranial pressure (ICP), the variation of vasopressin levels, and the urine osmolality at baseline and during pneumoperitoneum. This is done in an effort to understand the compensatory measure used during pneumoperitoneum and abdominal compartment syndrome
Measured: Intraoperative - approximately 45-60 minutes (Baseline, 10-15 minutes after pneumoperitoneum, 10-15 minutes after PEEP increase, and 10-15 minutes after desufflation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start28 Apr 2017
- Primary completion28 May 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intracranial Pressure IncreaseStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective trial
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emanuele LoMenzo, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03707054
- Sponsor's protocol ID
- FLA 17-031
- Status last verified
- Dec 2025
- First submitted
- 22 Jun 2018
- Last updated
- 29 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Vasopressin and Renal Function Following a Controlled Intraabdominal Pressure Elevation
- ClinicalTrials.gov ID
- NCT03707054
- Acronym / sponsor ID
- FLA 17-031
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 28 Apr 2017 (actual)
- Primary completion
- 28 May 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 16 Oct 2018 (actual)
- Results
- Posted 29 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate any direct correlation between increased intrathoracic pressure, intraabdominal pressure and intracranial pressure, following a controlled elevation in intraabdominal pressure and intrathoracic pressure (PEEP). The second end-point is to investigate any correlation between elevated intracranial pressure and vasopressin release, urine output and urine and serum osmolality by measuring their values at different time-points.
Detailed description
Increase in intraabdominal pressure (IAP) has been demonstrated to correlate with consequential hemodynamic effects. Several studies have been carried out mostly in experimental settings to define the underlying mechanisms that regulate the pathophysiology following an increase in IAP. In the last years this topic has become concerning because of the wide spread of laparoscopy, that is namely an iatrogenic acute increase in IAP.
Patients selected and consented for elective surgery will undergo standard of care and additional measurements during and after surgery. The measurements will be done at different stages of laparoscopic surgery.
- A) Baseline, patient under general anesthesia, Foley catheter positioned, beginning urine collection, before insufflation of pneumoperitoneum
- B) 10-15 minutes after insufflation of pneumoperitoneum at 15mmHg, PEEP at 5cmH2O or lowest setting
- C) 10-15 minutes after stabilization of PEEP at 10cmH2O, pneumoperitoneum still at 15 mmHg
- D) 10-15 minutes after desufflation of pneumoperitoneum and basal mechanical ventilation
Measurements include :
- Intraabdominal pressure IAP: assessed via laparoscopic insufflator, set at 15 mmHg as a standard value for all laparoscopic procedures
- Intrathoracic pressure: indirectly measured by variability of peak expiratory pressures
- Urine collection: through a Foley catheter from the beginning of surgery to post-operative day 1
- Urine osmolality (to be assessed at set time-points )
- Hourly urine output (at least 24 hours in order to evaluate expected significant variation even after the procedure end, since renal adaptation could take longer period)
- Serum/plasma collection : blood draws to evaluate specific values of
- Plasma Vasopressin (ADH)
- Serum osmolality
- Mean arterial pressure : standard of care
- Pulmonary expiratory end-pressure (PEEP): anesthesiologists routinely adapt PEEP in order to maintain an optimal ventilation, especially in obese patients and during laparoscopy
- Optic nerve sheath diameter (ONSD): a 7.5-MHz linear ultrasound probe to measure the diameter of the optic nerve sheath 3 mm behind the globe is going to be used; a trained study personnel physician will take the non-invasive sonographic picture using ultrasound. The ONSD will be measured from the captured picture. Study personnel will record the interaction on the patient's chart and include the measurement on the database
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective trial
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Experimental | Diagnostic Test: Study ArmMeasurements of optic nerve diameter, Urine and plasma osmolality, Serum vasopressin. |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-72
- Patients meeting NIH criteria for bariatric surgery
- Patients undergoing laparoscopic sleeve gastrectomy
Key exclusion criteria (7 listed)
- • Age below 18 years
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 |
|---|---|---|
| Study ArmMeasurements of optic nerve diameter, serum and urine osmolarity, serum vasopressin | Diagnostic test | Study Arm |
Primary outcome
Changes in Vasopressin Levels During Pneumoperitoneum and Elevated PEEP
Time frame: Intraoperative - approximately 45-60 minutes (Baseline, 10-15 minutes after pneumoperitoneum, 10-15 minutes after PEEP increase, and 10-15 minutes after desufflation)
The investigators will measure the intrabdominal pressure (IAP) pressure using the laparoscopic insufflator dial, the optic nerve sheath diameter (OSND) using an ultrasound which is a surrogate of the intracranial pressure (ICP), the variation of vasopressin levels, and the urine osmolality at baseline and during pneumoperitoneum. This is done in an effort to understand the compensatory measure used during pneumoperitoneum and abdominal compartment syndrome
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Intracranial Pressure Increase
Not yet recruitingObservational study
Decompressive Craniectomy After Aneurysmal Subarachnoid Hemorrhage (DECIDE-SAH)
Aneurysmal Subarachnoid Hemorrhage
Not yet recruitingObservational study
TCD and ONSD for Early Risk Stratification of Traumatic Brain Injury
Traumatic Brain Injury
RecruitingPhase 4
Tirzepatide in Idiopathic Intracranial Hypertension Trial
Idiopathic Intracranial Hypertension (IIH)
Active, not recruitingObservational study
TCD and ONSD for Noninvasive Assessment of Increased ICP in TBI
Intracranial Pressure Increase, Traumatic Brain Injuries
Not yet recruiting
The Effect of Ciprofol Versus Propofol Anesthesia on Postoperative Neurological Complications
Intracranial Tumors
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study Arm in people with Intracranial Pressure Increase and Abdominal Compartment Syndrome, run by The Cleveland Clinic at 1 site in United States.
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 3 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 29 Apr 2026. 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 United States. 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?
Yes. Results are posted in the registry (first posted 29 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Vasopressin Levels During Pneumoperitoneum and Elevated PEEP (time frame: Intraoperative - approximately 45-60 minutes (Baseline, 10-15 minutes after pneumoperitoneum, 10-15 minutes after PEEP increase, and 10-15 minutes after desufflation)). 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 29 Apr 2026.