Efficacy and Safety Profile of Cisatracurium Besylate for IAH

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Intra-abdominal Hypertension

Intervention / Treatment
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* Drug: Cisatracurium Besylate
* Drug: saline 0.12ml/kg/hr


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: test group<br>Participants in the test group received Cisatracurium Besilate 0.12mg/kg/hr Continuous infusion During intubation | Drug: Cisatracurium Besylate<br>* Participants in the test group received Cisatracurium Besylate 0.12mg/kg/hr continuous infusion during intubation。<br>|
| Sham Comparator: control group<br>Participants in the control group received saline 0.12ml/kg/hr Continuous infusion During intubation | Drug: saline 0.12ml/kg/hr<br>* saline 0.12ml/kg/hr<br>|

What is the study measuring?
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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 |