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Vasopressin in Intraabdominal Pressure Elevation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03707054
Recruitment Status : Active, not recruiting
First Posted : October 16, 2018
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Raul Rosenthal, The Cleveland Clinic

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.

Condition or disease Intervention/treatment Phase
Intracranial Pressure Increase Abdominal Compartment Syndrome Diagnostic Test: Study Arm Not Applicable

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.

  1. A) Baseline, patient under general anesthesia, Foley catheter positioned, beginning urine collection, before insufflation of pneumoperitoneum
  2. B) 10-15 minutes after insufflation of pneumoperitoneum at 15mmHg, PEEP at 5cmH2O or lowest setting
  3. C) 10-15 minutes after stabilization of PEEP at 10cmH2O, pneumoperitoneum still at 15 mmHg
  4. 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: prospective trial
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Correlation Between Vasopressin and Renal Function Following a Controlled Intraabdominal Pressure Elevation
Actual Study Start Date : April 28, 2017
Estimated Primary Completion Date : December 28, 2020
Estimated Study Completion Date : December 28, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study Arm
Measurements of optic nerve diameter, Urine and plasma osmolality, Serum vasopressin.
Diagnostic Test: Study Arm
Measurements of optic nerve diameter, serum and urine osmolarity, serum vasopressin




Primary Outcome Measures :
  1. Physiologic variations secondary to pneumoperitoneum [ Time Frame: 24 hours ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707054


Locations
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United States, Florida
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Sponsors and Collaborators
The Cleveland Clinic
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Responsible Party: Raul Rosenthal, Chairman Department of Surgery, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03707054    
Other Study ID Numbers: FLA 17-031
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Compartment Syndromes
Intra-Abdominal Hypertension
Intracranial Hypertension
Muscular Diseases
Musculoskeletal Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases