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Efficacy and Safety Profile of Cisatracurium Besylate for IAH

Primary Purpose

Intra-abdominal Hypertension

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cisatracurium Besylate
saline 0.12ml/kg/hr
Sponsored by
Tianjin Nankai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intra-abdominal Hypertension

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Intra-abdominal pressure≥12mmHg
  2. Age ≥18 years old
  3. Obtain informed consent.

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    test group

    control group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Duration of organ failure
    The time of organ failure recovered
    Duration of mechanical ventilation in patients with endotracheal intubation in ICU
    Duration of mechanical ventilation in patients with endotracheal intubation in ICU
    Length of stay in hospital
    ICU stay time and hospitalization time

    Full Information

    First Posted
    December 27, 2021
    Last Updated
    July 20, 2022
    Sponsor
    Tianjin Nankai Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05172531
    Brief Title
    Efficacy and Safety Profile of Cisatracurium Besylate for IAH
    Official Title
    Efficacy and Safety Profile of Cisatracurium Besylate for Intra-abdominal Hypertensiona: Single Center, Randomized, Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 29, 2022 (Anticipated)
    Primary Completion Date
    January 30, 2023 (Anticipated)
    Study Completion Date
    April 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tianjin Nankai Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    Detailed Description
    Title: Title: Efficacy and Safety Profile of Cisatracurium Besylate on Intra-abdominal hypertension: A Randomized Clinical Trial Research center: single center Design of the research: A randomized, double-blind and parallel controlled study Object of the research: The patients over 18 years that Intra-abdominal pressure over 12mmHg. Sample size of the research: A total of 80patients,40 cases in each group Interventions: Participants in the test group received Cisatracurium Besylate 0.12mg/kg/hr continuous infusion during intubation.while participants in the control group was the same as the test group except for received the same volume of saline instead of Cisatracurium Besylate.TOF-Watch was used to monitor the function of nerve and muscle in two groups and the dose was adjusted according to the TOF value. The aim of the research:To investigate the effect of Cisatracurium Besylate on IIntra-abdominal hypertension or abdominal compartment syndrome. Outcome #Primary outcomes: mortality. Secondary outcomes: Duration of organ failure; Time for enteral nutrition to reach the standard (30kcal/kg); Mechanical ventilation time; Length of hospital stay The estimated duration of the study#1-2years

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intra-abdominal Hypertension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    test group
    Arm Type
    Experimental
    Arm Description
    Participants in the test group received Cisatracurium Besilate 0.12mg/kg/hr Continuous infusion During intubation
    Arm Title
    control group
    Arm Type
    Sham Comparator
    Arm Description
    Participants in the control group received saline 0.12ml/kg/hr Continuous infusion During intubation
    Intervention Type
    Drug
    Intervention Name(s)
    Cisatracurium Besylate
    Intervention Description
    Participants in the test group received Cisatracurium Besylate 0.12mg/kg/hr continuous infusion during intubation。
    Intervention Type
    Drug
    Intervention Name(s)
    saline 0.12ml/kg/hr
    Intervention Description
    saline 0.12ml/kg/hr
    Primary Outcome Measure Information:
    Title
    All-cause 28-day mortality
    Description
    All reasons (such as infection, hemorrhage) caused the mortality during the first 28 days after treatments
    Time Frame
    1-2year
    Secondary Outcome Measure Information:
    Title
    Duration of organ failure
    Description
    The time of organ failure recovered
    Time Frame
    an average of 1-2 year
    Title
    Duration of mechanical ventilation in patients with endotracheal intubation in ICU
    Description
    Duration of mechanical ventilation in patients with endotracheal intubation in ICU
    Time Frame
    an average of 1 year
    Title
    Length of stay in hospital
    Description
    ICU stay time and hospitalization time
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Intra-abdominal pressure≥12mmHg Age ≥18 years old Obtain informed consent. Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ya Wu
    Phone
    15364689975
    Email
    yawu223202@163.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    33480617
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    33984016
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12675044
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22013257
    Citation
    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.
    Results Reference
    background

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    Efficacy and Safety Profile of Cisatracurium Besylate for IAH

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