Intracranial Pressure Increase Clinical Trial
Official title:
Correlation Between Vasopressin and Renal Function Following a Controlled Intraabdominal Pressure Elevation
Verified date | December 2022 |
Source | The Cleveland Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 16 |
Est. completion date | December 31, 2023 |
Est. primary completion date | July 28, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 72 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Florida | Weston | Florida |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Physiologic variations secondary to pneumoperitoneum | 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 | 24 hours |
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