Vasopressin in Intraabdominal Pressure Elevation

NCT03707054 | Completed Results DMC FDA Device

• 1 other identifier: FLA 17-031
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intracranial Pressure Increase; Abdominal Compartment Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

  Intraoperative - approximately 45-60 minutes (Baseline, 10-15 minutes after pneumoperitoneum, 10-15 minutes after PEEP increase, and 10-15 minutes after desufflation)

Study Arms (1)

Study Arm

EXPERIMENTAL

Measurements of optic nerve diameter, Urine and plasma osmolality, Serum vasopressin.

Diagnostic Test: Study Arm

Interventions

Study Arm DIAGNOSTIC_TEST

Measurements of optic nerve diameter, serum and urine osmolarity, serum vasopressin

Study Arm

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-72
• Patients meeting NIH criteria for bariatric surgery
• Patients undergoing laparoscopic sleeve gastrectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

MeSH Terms

Conditions

Intracranial Hypertension; Intra-Abdominal Hypertension

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Emanuele Lo Menzo
• Organization: Cleveland Clinic Florida

lomenze@ccf.org

9546595249

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: prospective trial

Study Record Dates

• First Submitted: June 22, 2018
• First Posted: October 16, 2018
• Study Start: April 28, 2017
• Primary Completion: May 28, 2024
• Study Completion: December 31, 2024
• Last Updated: April 29, 2026
• Results First Posted: April 29, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)