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Saudi Outcomes of ECMO-treated MERS-CoV Patients

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ClinicalTrials.gov Identifier: NCT02627378
Recruitment Status : Completed
First Posted : December 10, 2015
Last Update Posted : December 10, 2015
Sponsor:
Collaborators:
Ministry of Health, Saudi Arabia
King Abdulaziz University
Information provided by (Responsible Party):
Dammam University

Brief Summary:

A highly pathogenic human coronavirus causing respiratory disease emerged in Saudi Arabia in 2012. This viral infection termed Middle East respiratory syndrome coronavirus (MERS-CoV) is associated with high mortality rate in approximately 36% of reported patients.

The World Health Organization (WHO) reported 1,374 laboratory-confirmed worldwide infections, including at least 490 related deaths, from September, 2012, to July 24, 2015.2 The higher incidence of MERS-CoV infections in Saudi Arabia may be related to multiple factors, including seasonality, increased proactive screening, poor infection control measures, low relative humidity, and high temperature.

Infected patients with MERS-CoV usually have abnormal findings on chest radiography, ranging from subtle to extensive unilateral and bilateral abnormalities. MERS progresses rapidly to respiratory failure, in approximately 2/3 of infected patients, which has a high mortality rate, particularly in immunocompromised patients.

Extracorporeal membrane oxygenation (ECMO) has emerged as a rescue therapy in patients with refractory hypoxemia during the H1N1 epidemic.The use of veno-venous (VV)-ECMO provides respiratory support for patients with respiratory failure, whereas the use of veno-arterial (VA)-ECMO could be helpful in those with cardiorespiratory failure.10 However, the survival rate of the infected patients with H1N1 who required the use of ECMO varies considerably among the Caucasian and Asian countries (90% survival in Sweden and 83% in the UK13 vs. 35% in Japan). This large discrepancy could be explained with lack of satisfactory equipment, therapeutic guidelines, training of staff, and effective systems allowing patient transfer to the dedicated ECMO centres.

Guery and co-investigators described the use of ECMO in two French patients with cardiorespiratory failure secondary to MERS-CoV infection.This has been extended for treatment of refractory hypoxemic respiratory failure during the Saudi MERS-CoV outbreak.


Condition or disease Intervention/treatment Phase
MERS-CoV Infection Refractory Hypoxemia Other: Extracorporeal Membrane Oxygenation Other: Non Extracorporeal Membrane Oxygenation Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Extracorporeal Membrane Oxygenation Support for Middle East Respiratory Syndrome Induced Respiratory Failure
Study Start Date : September 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : October 2015

Arm Intervention/treatment
Active Comparator: Extracorporeal Membrane Oxygenation
Patients received Extracorporeal Membrane Oxygenation (ECMO) support
Other: Extracorporeal Membrane Oxygenation
Patients received veno-venous Extracorporeal Membrane Oxygenation (ECMO) support

Placebo Comparator: Non Extracorporeal Membrane Oxygenation
Patients did not receive Extracorporeal Membrane Oxygenation (ECMO) support
Other: Non Extracorporeal Membrane Oxygenation
Patients received no Extracorporeal Membrane Oxygenation (ECMO) support




Primary Outcome Measures :
  1. Mortality rate [ Time Frame: For 2 months after admission to hospital ]
    In-hospital mortality


Secondary Outcome Measures :
  1. Use of antiviral medications [ Time Frame: For 2 months after admission to hospital ]
    Use of ribavirin or other anti-viral medications

  2. Use of steroid medications [ Time Frame: For 2 months after admission to hospital ]
  3. Use of interferons [ Time Frame: For 2 months after admission to hospital ]
  4. Use of immunoglobulin [ Time Frame: For 2 months after admission to hospital ]
  5. Use of vasopressor medications [ Time Frame: For 2 months after admission to hospital ]
    Use of norepinephrine or vasopressin

  6. Use of inotropic medications [ Time Frame: For 2 months after admission to hospital ]
    Use of dobutamine, epinephrine, milirinone, levosimendan

  7. Need for renal replacement therapy [ Time Frame: For 2 months after admission to hospital ]
  8. Changes in blood cell count [ Time Frame: For 2 months after admission to hospital ]
    Changes in white and red blood cells and platelets counts

  9. Changes in renal function tests [ Time Frame: For 2 months after admission to hospital ]
    Changes in serum creatinine and blood urea nitrogen evels

  10. Changes in arterial blood gases levels [ Time Frame: For 2 months after admission to hospital ]
    Changes in arterial blood gases variables

  11. Ratio of arterial oxygen tension (PaO2) to the fraction of inspired oxygen (FiO2) (PaO2/FiO2 ratio) [ Time Frame: For 2 months after admission to hospital ]
  12. Use of alveolar recruitment technique [ Time Frame: For 2 months after admission to hospital ]
  13. Use of prone ventilation [ Time Frame: For 2 months after admission to hospital ]
  14. Use of neuromuscular blockades [ Time Frame: For 2 months after admission to hospital ]
  15. Bacterial co-infection [ Time Frame: For 2 months after admission to hospital ]
  16. Hospital length of stay [ Time Frame: For 2 months after admission to hospital ]
  17. ICU length of stay [ Time Frame: For 2 months after admission to hospital ]
  18. Extracorporeal membrane oxygenation support gas flow (liter/min) [ Time Frame: For 2 months after admission to hospital ]
  19. Extracorporeal membrane oxygenation support blood flow (liter/min/m2) [ Time Frame: For 2 months after admission to hospital ]
  20. Duration of Extracorporeal membrane oxygenation circulatory support [ Time Frame: For 2 months after admission to hospital ]

Other Outcome Measures:
  1. Number of participants with diabetes milletus on blood glucose test [ Time Frame: For 1 month before admission to hospital ]
  2. Number of participants with pregnancy on pregnancy test [ Time Frame: For 9 months before admission to hospital ]
  3. Number of participants with hypertension on blood pressure recordings [ Time Frame: For 1 month before admission to hospital ]
  4. Number of participants with acute kidney injury on renal function tests [ Time Frame: For 1 month before admission to hospital ]
  5. Number of participants with coronary artery disease on history, elctrocardiography and echocardiography [ Time Frame: For 1 month before admission to hospital ]
  6. Number of participants with congestive heart failure on echocardiography [ Time Frame: For 1 month before admission to hospital ]
  7. Number of participants with chronic kidney disease on renal function tests [ Time Frame: For 1 month before admission to hospital ]
  8. Number of participants with liver cell disease on liver function tests [ Time Frame: For 1 month before admission to hospital ]
  9. Number of participants with bronchial asthma on history and clinical examination [ Time Frame: For 1 month before admission to hospital ]
  10. Number of participants with chronic obstructive pulmonary disease on history, chest radiography and pulmonary function tests [ Time Frame: For 1 month before admission to hospital ]
  11. The presence of a predefined immunosuppression disease [ Time Frame: For 1 month before admission to hospital ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Positive infection with Middle East Respiratory Syndrome virus
  • Refractory hypoxemic respiratory failure
  • Eligible for use of extracorporeal membrane oxygenation support (ECMO)

Exclusion Criteria:

  • Neonates
  • Children
  • Patients treated with ECMO for primary cardiac failure
  • Following heart transplantation
  • Following lung transplantation
  • Following cardiac surgery
  • Patients with an alternative diagnosis who had no virus isolated

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): NCT02627378


Locations
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Saudi Arabia
Dammam University KFHU
Al-Khobar, EP, Saudi Arabia, 31952
Sponsors and Collaborators
Dammam University
Ministry of Health, Saudi Arabia
King Abdulaziz University
Investigators
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Principal Investigator: Anees Sindi, FRCPC King Abdulaziz University, Jeddah, Saudi Arabia
Study Director: Muhammed S Alshahrani, FRCPC University of Dammam, Dammam, Saudi Arabia
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Responsible Party: Dammam University
ClinicalTrials.gov Identifier: NCT02627378    
Other Study ID Numbers: A-00190
First Posted: December 10, 2015    Key Record Dates
Last Update Posted: December 10, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory