Efficacy and Safety Profile of Cisatracurium Besylate for IAH

Intra-abdominal Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05172531
• Other study ID #: NKYY-IAH-2021-12
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 29, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: July 2022
• Source: Tianjin Nankai Hospital
• Contact: Ya Wu
• Phone: 15364689975
• Email: yawu223202[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: April 1, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Intra-abdominal Hypertension

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Nankai Hospital

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause 28-day mortality	All reasons (such as infection, hemorrhage) caused the mortality during the first 28 days after treatments	1-2year
Secondary	Duration of organ failure	The time of organ failure recovered	an average of 1-2 year
Secondary	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
Secondary	Length of stay in hospital	ICU stay time and hospitalization time	24 months