Intra-abdominal HypertensionNCT05172531
Efficacy and Safety Profile of Cisatracurium Besylate for IAH
A study testing Cisatracurium Besylate and saline 0.12ml/kg/hr in people with Intra-abdominal Hypertension, run by Tianjin Nankai Hospital.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Intra-abdominal Hypertension
- What is being tested?
- Cisatracurium Besylate and saline 0.12ml/kg/hr
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 29 Aug 2022to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intra-abdominal pressure≥12mmHg
- Age ≥18 years old
- Obtain informed consent.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety Profile of Cisatracurium Besylate for Intra-abdominal Hypertensiona: Single Center, Randomized, Controlled Trial
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.
Read the detailed description
- 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
- Conditions
- Intra-abdominal Hypertension
- Being tested
- Cisatracurium Besylate, saline 0.12ml/kg/hr
- Medical subject headings
- Intra-Abdominal Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cisatracurium BesylateDrug
Participants in the test group received Cisatracurium Besylate 0.12mg/kg/hr continuous infusion during intubation。
saline 0.12ml/kg/hrDrug
saline 0.12ml/kg/hr
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | Participants in the test group received Cisatracurium Besilate 0.12mg/kg/hr Continuous infusion During intubation Receives: Drug: Cisatracurium Besylate |
| control group | Sham comparator | Participants in the control group received saline 0.12ml/kg/hr Continuous infusion During intubation Receives: Drug: saline 0.12ml/kg/hr |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause 28-day mortality
All reasons (such as infection, hemorrhage) caused the mortality during the first 28 days after treatments
Measured: 1-2year
Secondary outcomes (3)
Duration of organ failure
The time of organ failure recovered
Measured: 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
Measured: an average of 1 year
Length of stay in hospital
ICU stay time and hospitalization time
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start29 Aug 2022 (estimated)
- Primary completion30 Jan 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intra-abdominal HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Nankai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianbo Yu, Tianjin Nankai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172531
- Sponsor's protocol ID
- NKYY-IAH-2021-12
- Status last verified
- Jul 2022
- First submitted
- 27 Dec 2021
- Last updated
- 22 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33480617Pereira 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.
PubMed 33984016De 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.
PubMed 12675044Chiles 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.
PubMed 22013257
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Profile of Cisatracurium Besylate for Intra-abdominal Hypertensiona: Single Center, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT05172531
- Acronym / sponsor ID
- NKYY-IAH-2021-12
- Conditions
- Intra-abdominal Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tianjin Nankai HospitalUniversity, hospital or other
- Study start
- 29 Aug 2022 (estimated)
- Primary completion
- 30 Jan 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Drug: Cisatracurium BesylateParticipants in the test group received Cisatracurium Besilate 0.12mg/kg/hr Continuous infusion During intubation |
| control group | Sham comparator | Drug: saline 0.12ml/kg/hrParticipants in the control group received saline 0.12ml/kg/hr Continuous infusion During intubation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Intra-abdominal pressure≥12mmHg
- Age ≥18 years old
- Obtain informed consent.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cisatracurium BesylateParticipants in the test group received Cisatracurium Besylate 0.12mg/kg/hr continuous infusion during intubation。 | Drug | test group |
| saline 0.12ml/kg/hrsaline 0.12ml/kg/hr | Drug | control group |
Primary outcome
All-cause 28-day mortality
Time frame: 1-2year
All reasons (such as infection, hemorrhage) caused the mortality during the first 28 days after treatments
3 secondary outcomes
Duration of organ failure
Time frame: an average of 1-2 year
Duration of mechanical ventilation in patients with endotracheal intubation in ICU
Time frame: an average of 1 year
Length of stay in hospital
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Background: PubMed 33480617Kimball 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.
- Background: PubMed 33984016Pereira 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.
- Background: PubMed 12675044De 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.
- Background: PubMed 22013257Chiles 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Cisatracurium Besylate and saline 0.12ml/kg/hr in people with Intra-abdominal Hypertension, run by Tianjin Nankai Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ya Wu (15364689975, yawu223202@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause 28-day mortality (time frame: 1-2year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05172531, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.