N/A
N=16
Vasopressin in Intraabdominal Pressure Elevation
Intracranial Pressure Increase · Abdominal Compartment Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03707054 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Changes in Vasopressin Levels During Pneumoperitoneum and Elevated PEEP — 2.37; 45.48; 54.75; 31.57 pg/ml — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Study Arm (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Vasopressin Levels During Pneumoperitoneum and Elevated PEEP |
2.37; 45.48; 54.75; 31.57 | <0.0001 sig |
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). 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.
Eligibility Criteria
Inclusion Criteria
- Age 18-72
- Patients meeting NIH criteria for bariatric surgery
- Patients undergoing laparoscopic sleeve gastrectomy
Exclusion Criteria
- • 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
Data sourced from ClinicalTrials.gov (NCT03707054). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.