Efficacy and Safety Profile of Cisatracurium Besylate for IAH

Overview

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.

Full Title of Study: “Efficacy and Safety Profile of Cisatracurium Besylate for Intra-abdominal Hypertensiona: Single Center, Randomized, Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: January 30, 2023

Detailed Description

1. Title: Title: Efficacy and Safety Profile of Cisatracurium Besylate on Intra-abdominal hypertension: A Randomized Clinical Trial 2. Research center: single center 3. Design of the research: A randomized, double-blind and parallel controlled study 4. Object of the research: The patients over 18 years that Intra-abdominal pressure over 12mmHg. 5. Sample size of the research: A total of 80patients,40 cases in each group 6. 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. 7. The aim of the research:To investigate the effect of Cisatracurium Besylate on IIntra-abdominal hypertension or abdominal compartment syndrome. 8. 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 9. The estimated duration of the study#1-2years

Interventions

  • Drug: Cisatracurium Besylate
    • Participants in the test group received Cisatracurium Besylate 0.12mg/kg/hr continuous infusion during intubation。
  • Drug: saline 0.12ml/kg/hr
    • saline 0.12ml/kg/hr

Arms, Groups and Cohorts

  • Experimental: test group
    • Participants in the test group received Cisatracurium Besilate 0.12mg/kg/hr Continuous infusion During intubation
  • Sham Comparator: control group
    • Participants in the control group received saline 0.12ml/kg/hr Continuous infusion During intubation

Clinical Trial Outcome Measures

Primary Measures

  • All-cause 28-day mortality
    • Time Frame: 1-2year
    • All reasons (such as infection, hemorrhage) caused the mortality during the first 28 days after treatments

Secondary Measures

  • Duration of organ failure
    • Time Frame: an average of 1-2 year
    • The time of organ failure recovered
  • Duration of mechanical ventilation in patients with endotracheal intubation in ICU
    • Time Frame: an average of 1 year
    • Duration of mechanical ventilation in patients with endotracheal intubation in ICU
  • Length of stay in hospital
    • Time Frame: 24 months
    • ICU stay time and hospitalization time

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tianjin Nankai Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jianbo Yu, Department of anesthesiology , Director, Chief physician – Tianjin Nankai Hospital
  • Overall Contact(s)
    • Ya Wu, 15364689975, yawu223202@163.com

References

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.

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.

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.

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.

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