Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00299650 |
Recruitment Status :
Completed
First Posted : March 7, 2006
Last Update Posted : October 10, 2008
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
ARDS | Drug: cisatracurium Drug: Placebo Drug: Cisatracurium besilate | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 340 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Systematic Early Use of Neuromuscular Blocking Agents in ARDS Patients |
Study Start Date : | March 2006 |
Actual Primary Completion Date : | October 2008 |
Actual Study Completion Date : | October 2008 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: A |
Drug: Placebo
physiological serum infusion |
Active Comparator: B |
Drug: cisatracurium Drug: Cisatracurium besilate Cisatracurium besilate infusion (900mg/day) |
- Reduction of the mortality rate of ARDS patients at d90 [ Time Frame: 36 months ]
- Mortality at day 28, day 60, day 180 and ICU mortality, Ventilator-free days and alive at day 28 and day 60, Exposure time to FIO2 > 80% or PEEP > 10 cmH2O during the first 7 days, Sedatives and analgesics requirements during the first 7 days [ Time Frame: march 2009 ]
- Organ failure-free days and alive at day 28, Incidence of barotrauma, Incidence of critical illness neuromyopathy, Incidence of ventilator-associated pneumonia, Quality of life at day 180 [ Time Frame: march 2009 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ARDS with a PaO2 / FiO2 < 150 with a PEEP > 5 since less than 48 hrs
- informed consent
Exclusion Criteria:
- NMBA allergy
- Continuous administration of NMBA for ARDS prior inclusion
- Age < 18 yrs
- SAPS II > 70
- Persistent air leak

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00299650

Principal Investigator: | Laurent Papazian, MD | Assistance Publique Hôpitaux de Marseille |
Responsible Party: | Pr PAPAZIAN Laurent, ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE |
ClinicalTrials.gov Identifier: | NCT00299650 |
Other Study ID Numbers: |
ACURASYS PHRC 2004 |
First Posted: | March 7, 2006 Key Record Dates |
Last Update Posted: | October 10, 2008 |
Last Verified: | October 2008 |
ARDS mortality mechanical ventilation pneumonia muscle relaxants |
Cisatracurium Atracurium Neuromuscular Blocking Agents Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Neuromuscular Nondepolarizing Agents Nicotinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |