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Targeting Abdominal Perfusion Pressure in Septic Shock

NCT03582046 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-01-13

No results posted yet for this study

Summary

A randomized control trial among patients with septic shock, studying the incidence, progression and recovery of AKI.

Conditions

Interventions

DEVICE

Abdominal Perfusion Pressure (APP)

Intra-abdominal Pressure (IAP) actively measured and recorded every four hours, and mean arterial pressure (MAP) adjusted to maintain abdominal perfusion pressure (APP) levels ≥ 60 mmHg.

DEVICE

Mean Arterial Pressure (MAP)

Intra-abdominal Pressure (IAP) recorded passively in device, but not measured or reviewed by physician. Patient will be treated with sepsis standard of care, maintaining mean arterial pressure (MAP) of ≥ 65 mmHg.

Sponsors & Collaborators

  • Emory University

    collaborator OTHER

  • University of Arkansas

    collaborator OTHER

  • Central Arkansas Veterans Healthcare System

    collaborator FED

  • Potrero Medical

    lead INDUSTRY

Principal Investigators

  • Michael J Connor, MD · Emory University School of Medicine, (404) 616-0184 [email protected]

  • Luis Juncos, MD · CAVHS, Little Rock, AR 72205 (501) 257-1000 [email protected]

  • Nithin Karakala, MD · University of Arkansas Medical Center, Little Rock, AR [email protected]

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-05
Primary Completion
2020-02-27
Completion
2020-06-20
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03582046 on ClinicalTrials.gov