Efficacy and Safety Profile of Cisatracurium Besylate for IAH

Not Applicable

• Conditions: Intra-abdominal Hypertension
• Interventions: Drug: Cisatracurium Besylate; Drug: saline 0.12ml/kg/hr

• Registration Number: NCT05172531
• Lead Sponsor: Tianjin Nankai Hospital

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

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 Timeline

• Study First Submitted: 2021-12-27
• Study First Submitted QC: 2021-12-28
• Study First Posted: 2021-12-29
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-20
• Last Update Posted: 2022-07-22
• Study Start: 2022-08-29
• Primary Completion: 2023-01-30
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
test group	Cisatracurium Besylate	Participants in the test group received Cisatracurium Besilate 0.12mg/kg/hr Continuous infusion During intubation
control group	saline 0.12ml/kg/hr	Participants in the control group received saline 0.12ml/kg/hr Continuous infusion During intubation

Primary Outcome Measures

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

Secondary Outcome Measures

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