NCT05172531

Brief Summary

This study is a randomized, double-blinded, controlled design. In this study, Cisatracurium Besylate was selected for treatment in Intra-abdominal hypertension or abdominal compartment syndrome,accompanied with evaluating the effects on the duration of organ failure,length of hospital stay and mortality.To clarify the effect of Cisatracurium Besylate on IAH/ACS is of great significance to the clinical applications.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 29, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

August 29, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

July 22, 2022

Status Verified

July 1, 2022

Enrollment Period

5 months

First QC Date

December 27, 2021

Last Update Submit

July 20, 2022

Conditions

Intra-abdominal Hypertension

Outcome Measures

Primary Outcomes (1)

  • All-cause 28-day mortality

    All reasons (such as infection, hemorrhage) caused the mortality during the first 28 days after treatments

    1-2year

Secondary Outcomes (3)

  • Duration of organ failure

    an average of 1-2 year

  • Duration of mechanical ventilation in patients with endotracheal intubation in ICU

    an average of 1 year

  • Length of stay in hospital

    24 months

Study Arms (2)

test group

EXPERIMENTAL

Participants in the test group received Cisatracurium Besilate 0.12mg/kg/hr Continuous infusion During intubation

Drug: Cisatracurium Besylate

control group

SHAM COMPARATOR

Participants in the control group received saline 0.12ml/kg/hr Continuous infusion During intubation

Drug: saline 0.12ml/kg/hr

Interventions

Cisatracurium BesylateDRUG

Participants in the test group received Cisatracurium Besylate 0.12mg/kg/hr continuous infusion during intubation。

test group
saline 0.12ml/kg/hrDRUG

saline 0.12ml/kg/hr

control group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Intra-abdominal pressure≥12mmHg
  • Age ≥18 years old
  • Obtain informed consent.

You may not qualify if:

  • Pregnancy pancreatitis
  • Patients who have undergone percutaneous puncture or surgical drainage before admission, and have undergone surgical decompression due to early abdominal hypertension
  • Patients with a history of chronic organ dysfunction (such as uremia, COPD, liver cirrhosis, heart failure, etc.)
  • Those who refuse to participate in the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Kimball EJ. Intra-abdominal hypertension and abdominal compartment syndrome: a current review. Curr Opin Crit Care. 2021 Apr 1;27(2):164-168. doi: 10.1097/MCC.0000000000000797.

    PMID: 33480617BACKGROUND

  • Pereira R, Buglevski M, Perdigoto R, Marcelino P, Saliba F, Blot S, Starkopf J. Intra-abdominal hypertension and abdominal compartment syndrome in the critically ill liver cirrhotic patient-prevalence and clinical outcomes. A multicentric retrospective cohort study in intensive care. PLoS One. 2021 May 13;16(5):e0251498. doi: 10.1371/journal.pone.0251498. eCollection 2021.

    PMID: 33984016BACKGROUND

  • De Waele JJ, Benoit D, Hoste E, Colardyn F. A role for muscle relaxation in patients with abdominal compartment syndrome? Intensive Care Med. 2003 Feb;29(2):332. doi: 10.1007/s00134-002-1578-x. No abstract available.

    PMID: 12675044BACKGROUND

  • Chiles KT, Feeney CM. Abdominal compartment syndrome successfully treated with neuromuscular blockade. Indian J Anaesth. 2011 Jul;55(4):384-7. doi: 10.4103/0019-5049.84867.

    PMID: 22013257BACKGROUND

MeSH Terms

Conditions

Intra-Abdominal Hypertension

Interventions

cisatracuriumSodium Chloride

Condition Hierarchy (Ancestors)

Compartment SyndromesMuscular DiseasesMusculoskeletal DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Central Study Contacts

Ya Wu

CONTACT

15364689975yawu223202@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of anesthesiology , Director, Chief physician

Study Record Dates

First Submitted

December 27, 2021

First Posted

December 29, 2021

Study Start

August 29, 2022

Primary Completion

January 30, 2023

Study Completion

April 1, 2023

Last Updated

July 22, 2022

Record last verified: 2022-07