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Comparison for the Effect of Neuromuscular Blocking Agents Versus Sedation Alone on Severe ARDS Patients Due to COVID-19

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04922814
Recruitment Status : Not yet recruiting
First Posted : June 11, 2021
Last Update Posted : June 11, 2021
Sponsor:
Information provided by (Responsible Party):
Ayman Abd El-Khalek Mohammed Glala, Assiut University

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Acute Respiratory Distress Syndrome Sedation Complication ICU Acquired Weakness Drug: muscle relaxation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Comparison for the Effect of Neuromuscular Blocking Agents Versus Sedation Alone on Severe ARDS Patients Due to COVID-19
Estimated Study Start Date : August 1, 2021
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control group(group A)
Only sedation for mechanically ventilated COVID patients
Experimental: Muscle relaxant group(group B)
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.
 Drug: muscle relaxation
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.


Outcome Measures
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Primary Outcome Measures :
  1. PaO2/FiO2 [ Time Frame: 48 hours ]
    ratio of arterial oxygen pressure in millilitre mercury to fraction of inspired oxygen at same time within the arterial blood gas


Secondary Outcome Measures :
  1. Change in lung mechanics [ Time Frame: 48 hours ]
    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

  2. SOFA score [ Time Frame: 48 hours ]
    Fulfilment of modified SOFA (Sepsis Organ Failure Assessment) score sheet

  3. Measurement of tissue perfusion [ Time Frame: 48 hours ]
    Measurement of tissue perfusion by serum lactate in mmol/L and jugular venous oxygen saturation % from a sample withdrawn from CVP

  4. Monitoring of Alveolar - Arterial Oxygen difference [ Time Frame: 48 hours ]

    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]

  5. 28 days survival [ Time Frame: after 28 days ]
    28 days survival

  6. Recording risk factors [ Time Frame: 28 days ]
    Recording risk factors as diabetes, renal failure, immunosuppression, smoking, COPD and obesity

  7. Recording complications [ Time Frame: 28 days ]
    Recording complications as VAP, HAP, neuromuscular weakness


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

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): NCT04922814


Contacts
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Contact: Ayman Abdel Khalek Abou Glala, MD 0102 567 5901 Aymanglala24@gmail.com
Contact: Ahmed Talaat Ahmed Aly, MD 01062716629 Ahmedtalaat_ahmed@yahoo.com

Sponsors and Collaborators
Assiut University
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ayman Abd El-Khalek Mohammed Glala, Principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT04922814    
Other Study ID Numbers: Covid-19 ICU
First Posted: June 11, 2021    Key Record Dates
Last Update Posted: June 11, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury