Efficacy and Safety Profile of Cisatracurium Besylate for IAH

Efficacy and Safety Profile of Cisatracurium Besylate for Intra-abdominal Hypertensiona: Single Center, Randomized, Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intra-abdominal Hypertension
• Intervention / Treatment: Drug: Cisatracurium Besylate; Drug: saline 0.12ml/kg/hr

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

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ya Wu; Phone Number: 15364689975; Email: yawu223202@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: test group; Participants in the test group received Cisatracurium Besilate 0.12mg/kg/hr Continuous infusion During intubation	Drug: Cisatracurium Besylate; Participants in the test group received Cisatracurium Besylate 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	Drug: saline 0.12ml/kg/hr; saline 0.12ml/kg/hr

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tianjin Nankai Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 29, 2022
• Primary Completion (Anticipated): January 30, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: December 27, 2021
• First Submitted That Met QC Criteria: December 28, 2021
• First Posted (Actual): December 29, 2021

Study Record Updates

• Last Update Posted (Actual): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Musculoskeletal Diseases; Muscular Diseases; Compartment Syndromes; Intra-Abdominal Hypertension; Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Blocking Agents; Cisatracurium
• Other Study ID Numbers: NKYY-IAH-2021-12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No