Vasopressin in Intraabdominal Pressure Elevation (NCT03707054) | Clinical Trial Compass
CompletedNot Applicable
Vasopressin in Intraabdominal Pressure Elevation
United States16 participantsStarted 2017-04-28
Plain-language 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.
Who can participate
Age range
18 Years – 72 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in Vasopressin Levels During Pneumoperitoneum and Elevated PEEP
Timeframe: Intraoperative - approximately 45-60 minutes (Baseline, 10-15 minutes after pneumoperitoneum, 10-15 minutes after PEEP increase, and 10-15 minutes after desufflation)