Efficacy and Safety Profile of Cisatracurium Besylate for IAH

• Sponsor: Tianjin Nankai Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05172531
• Collaborator: (none)
• Enrollment: 80
• Arms: 2
• Anticipated Duration (Months): 7.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Intra-abdominal Hypertension	Drug: Cisatracurium Besylate; Drug: saline 0.12ml/kg/hr	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety Profile of Cisatracurium Besylate for Intra-abdominal Hypertensiona: Single Center, Randomized, Controlled Trial
• Anticipated Study Start Date: Aug 29, 2022
• Anticipated Primary Completion Date: Jan 30, 2023
• Anticipated Study Completion Date: Apr 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Duration of organ failure [an average of 1-2 year]

   The time of organ failure recovered

2. 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

3. Length of stay in hospital [24 months]

   ICU stay time and hospitalization time

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Tianjin Nankai Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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. Review.
• 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.

• Responsible Party: Jianbo Yu, Department of anesthesiology , Director, Chief physician, Tianjin Nankai Hospital
• ClinicalTrials.gov Identifier: NCT05172531
• Other Study ID Numbers: NKYY-IAH-2021-12
• First Posted: Dec 29, 2021
• Last Update Posted: Jul 22, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Intra-Abdominal Hypertension; Cisatracurium

Study Results

No Results Posted as of Jul 22, 2022