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
About this trial
This is an interventional treatment trial for Intra-abdominal Hypertension
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
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
NCT ID
NCT05172531
First Posted
December 27, 2021
Last Updated
July 20, 2022
Sponsor
Tianjin Nankai Hospital
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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