Back to resultsComparison for the Effect of Neuromuscular Blocking Agents Versus Sedation Alone on Severe ARDS Patients Due to COVID-19
Primary Purpose
COVID-19 Acute Respiratory Distress Syndrome, Sedation Complication, ICU Acquired Weakness
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
muscle relaxation
Sponsored by
About this trial
This is an interventional supportive care trial for COVID-19 Acute Respiratory Distress Syndrome
Eligibility Criteria
Inclusion Criteria:
- Severe ARDS: PaO2/FiO2 <200, resistant hypoxemia and tachypnoea (RR > 40 breath/minute)
- Not relieved by high frequency nasal canula or CPAP.
- Need for invasive mechanical ventilation (uncooperative)
Exclusion Criteria:
- Patient relatives' refusal
- Not mechanically ventilated.
- Combination of female, corticosteroids administration and vecuronium muscle relaxant.
- Neuromuscular diseases (especially demyelinating diseases).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group(group A)
Muscle relaxant group(group B)
Arm Description
Only sedation for mechanically ventilated COVID patients
They will receive muscle relaxation treatment for at least 48 hours. Cisatracurium will be given. Short term infusions up to 24 hours will be given in a dose rate of 2-3 mic/Kg/min followed by intervallic shots of 2-5 mg.
Outcomes
Primary Outcome Measures
PaO2/FiO2
ratio of arterial oxygen pressure in millilitre mercury to fraction of inspired oxygen at same time within the arterial blood gas
Secondary Outcome Measures
Change in lung mechanics
measurement of peak and plateau pressures in cm H2O, airway resistance in cm H2O. s/mL, static and dynamic compliance in Litre/cm H2O and positive end expiratory pressure in cm H2O from ventilator settings
SOFA score
Fulfilment of modified SOFA (Sepsis Organ Failure Assessment) score sheet
Measurement of tissue perfusion
Measurement of tissue perfusion by serum lactate in mmol/L and jugular venous oxygen saturation % from a sample withdrawn from CVP
Monitoring of Alveolar - Arterial Oxygen difference
An arterial canula is to be introduced and a quantity of 0.5 ml of blood samples are obtained from radial artery and arterial blood gas analysis are performed after anti-coagulation by heparin. Alveolar-arterial oxygen tension difference:
[P(A-a) DO2] = [(Pa-PH2O) × FiO2%-PaCO2-PaO2]
[(760-47) × FiO2%-PaCO2-PaO2]
[713 × FiO2%-PaCO2-PaO2]
28 days survival
28 days survival
Recording risk factors
Recording risk factors as diabetes, renal failure, immunosuppression, smoking, COPD and obesity
Recording complications
Recording complications as VAP, HAP, neuromuscular weakness
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04922814
Brief Title
Comparison for the Effect of Neuromuscular Blocking Agents Versus Sedation Alone on Severe ARDS Patients Due to COVID-19
Official Title
Comparison for the Effect of Neuromuscular Blocking Agents Versus Sedation Alone on Severe ARDS Patients Due to COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2021 (Anticipated)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Many questions about management of COVID-19 are still not answered. So, we recruit this study aiming to evaluate improvement of oxygenation in COVID-19 patients with severe ARDS, to improve morbidity and mortality of ICU covid patients, to participate in understanding of real hidden pathophysiology of COVID-19.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Acute Respiratory Distress Syndrome, Sedation Complication, ICU Acquired Weakness
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group(group A)
Arm Type
No Intervention
Arm Description
Only sedation for mechanically ventilated COVID patients
Arm Title
Muscle relaxant group(group B)
Arm Type
Experimental
Arm Description
They will receive muscle relaxation treatment for at least 48 hours. Cisatracurium will be given. Short term infusions up to 24 hours will be given in a dose rate of 2-3 mic/Kg/min followed by intervallic shots of 2-5 mg.
Intervention Type
Drug
Intervention Name(s)
muscle relaxation
Intervention Description
They will receive muscle relaxation treatment for at least 48 hours. Cisatracurium will be given. Short term infusions up to 24 hours will be given in a dose rate of 2-3 mic/Kg/min followed by intervallic shots of 2-5 mg.
Primary Outcome Measure Information:
Title
PaO2/FiO2
Description
ratio of arterial oxygen pressure in millilitre mercury to fraction of inspired oxygen at same time within the arterial blood gas
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Change in lung mechanics
Description
measurement of peak and plateau pressures in cm H2O, airway resistance in cm H2O. s/mL, static and dynamic compliance in Litre/cm H2O and positive end expiratory pressure in cm H2O from ventilator settings
Time Frame
48 hours
Title
SOFA score
Description
Fulfilment of modified SOFA (Sepsis Organ Failure Assessment) score sheet
Time Frame
48 hours
Title
Measurement of tissue perfusion
Description
Measurement of tissue perfusion by serum lactate in mmol/L and jugular venous oxygen saturation % from a sample withdrawn from CVP
Time Frame
48 hours
Title
Monitoring of Alveolar - Arterial Oxygen difference
Description
An arterial canula is to be introduced and a quantity of 0.5 ml of blood samples are obtained from radial artery and arterial blood gas analysis are performed after anti-coagulation by heparin. Alveolar-arterial oxygen tension difference:
[P(A-a) DO2] = [(Pa-PH2O) × FiO2%-PaCO2-PaO2]
[(760-47) × FiO2%-PaCO2-PaO2]
[713 × FiO2%-PaCO2-PaO2]
Time Frame
48 hours
Title
28 days survival
Description
28 days survival
Time Frame
after 28 days
Title
Recording risk factors
Description
Recording risk factors as diabetes, renal failure, immunosuppression, smoking, COPD and obesity
Time Frame
28 days
Title
Recording complications
Description
Recording complications as VAP, HAP, neuromuscular weakness
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Severe ARDS: PaO2/FiO2 <200, resistant hypoxemia and tachypnoea (RR > 40 breath/minute)
Not relieved by high frequency nasal canula or CPAP.
Need for invasive mechanical ventilation (uncooperative)
Exclusion Criteria:
Patient relatives' refusal
Not mechanically ventilated.
Combination of female, corticosteroids administration and vecuronium muscle relaxant.
Neuromuscular diseases (especially demyelinating diseases).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayman Abdel Khalek Abou Glala, MD
Phone
0102 567 5901
Email
Aymanglala24@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Talaat Ahmed Aly, MD
Phone
01062716629
Email
Ahmedtalaat_ahmed@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
32269085
Citation
Mason RJ. Pathogenesis of COVID-19 from a cell biology perspective. Eur Respir J. 2020 Apr 16;55(4):2000607. doi: 10.1183/13993003.00607-2020. Print 2020 Apr.
Results Reference
result
PubMed Identifier
22835162
Citation
Neto AS, Pereira VG, Esposito DC, Damasceno MC, Schultz MJ. Neuromuscular blocking agents in patients with acute respiratory distress syndrome: a summary of the current evidence from three randomized controlled trials. Ann Intensive Care. 2012 Jul 26;2(1):33. doi: 10.1186/2110-5820-2-33.
Results Reference
result
PubMed Identifier
20843245
Citation
Papazian L, Forel JM, Gacouin A, Penot-Ragon C, Perrin G, Loundou A, Jaber S, Arnal JM, Perez D, Seghboyan JM, Constantin JM, Courant P, Lefrant JY, Guerin C, Prat G, Morange S, Roch A; ACURASYS Study Investigators. Neuromuscular blockers in early acute respiratory distress syndrome. N Engl J Med. 2010 Sep 16;363(12):1107-16. doi: 10.1056/NEJMoa1005372.
Results Reference
result
PubMed Identifier
35767435
Citation
Hohmann F, Wedekind L, Grundeis F, Dickel S, Frank J, Golinski M, Griesel M, Grimm C, Herchenhahn C, Kramer A, Metzendorf MI, Moerer O, Olbrich N, Thieme V, Vieler A, Fichtner F, Burns J, Laudi S. Early spontaneous breathing for acute respiratory distress syndrome in individuals with COVID-19. Cochrane Database Syst Rev. 2022 Jun 29;6(6):CD015077. doi: 10.1002/14651858.CD015077.
Results Reference
derived
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Comparison for the Effect of Neuromuscular Blocking Agents Versus Sedation Alone on Severe ARDS Patients Due to COVID-19
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