Clinical trial NCT05172531: Efficacy and Safety Profile of Cisatracurium Besylate for IAH
Official title: Efficacy and Safety Profile of Cisatracurium Besylate for Intra-abdominal Hypertensiona: Single Center, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intra-abdominal Hypertension
Lead sponsor: Tianjin Nankai Hospital
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: All-cause 28-day mortality
timeFrame: 1-2year
Secondary outcomes:
measure: Duration of organ failure
timeFrame: an average of 1-2 year
measure: Duration of mechanical ventilation in patients with endotracheal intubation in ICU
timeFrame: an average of 1 year
measure: Length of stay in hospital
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
References:
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.
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.
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. doi: 10.1007/s00134-002-1578-x. No abstract available.
citation: 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.