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Vasopressin in Intraabdominal Pressure Elevation

Primary Purpose

Intracranial Pressure Increase, Abdominal Compartment Syndrome

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Study Arm
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Intracranial Pressure Increase

Eligibility Criteria

18 Years - 72 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cleveland Clinic Florida

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study Arm

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 22, 2018
Last Updated
December 19, 2022
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03707054
Brief Title
Vasopressin in Intraabdominal Pressure Elevation
Official Title
Correlation Between Vasopressin and Renal Function Following a Controlled Intraabdominal Pressure Elevation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 28, 2017 (Actual)
Primary Completion Date
July 28, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Pressure Increase, Abdominal Compartment Syndrome

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Arm
Arm Type
Experimental
Arm Description
Measurements of optic nerve diameter, Urine and plasma osmolality, Serum vasopressin.
Intervention Type
Diagnostic Test
Intervention Name(s)
Study Arm
Intervention Description
Measurements of optic nerve diameter, serum and urine osmolarity, serum vasopressin
Primary Outcome Measure Information:
Title
Physiologic variations secondary to pneumoperitoneum
Description
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
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Vasopressin in Intraabdominal Pressure Elevation

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