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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05172531
Other study ID # NKYY-IAH-2021-12
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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