Ethics approval and consent to participate
The study has been approved by the Institutional Review Board (IRB) of the Ministry of National Guard Health Affairs (MNGHA) and the respective Institutional Review Boards of all the other centers.
Consent for publication
Not applicable
Availability of data and materials
The data that will support the findings of this study are available from the corresponding author upon reasonable request as per the regulations of King Abdullah International Medical Research Center (KAIMRC).
Competing interests
The authors declare that they have no competing interests
Funding
The study is sponsored by King Abdullah International Medical Research Center, Ministry of National Guard Health Affairs MNGHA (Grant no: RC19/414R), Riyadh, Saudi Arabia. The study sponsor does not have any role in the study design, collection, management, and interpretation of the data or preparation, review, or approval of the manuscript or decision to submit the manuscript for publication.
Authors' contributions
YA is the Chief Investigator; conception, design and development of the protocol, analytical plan, drafting and critical revision of the manuscript for important and intellectual content. HMD, OD, MS, JJ, DM, HG, FH, AM, AG, GM, AF, AK, AB, KM, KG, GR, JC, HIA, MHS, NA, AA, RH, KS, MA, RQ, AQ, MH, HA, SQ, AG, SB, AO, SF, MA, OA, AAM, MO, SFB, WAF, JS, JCP, AP, JHA, WH, MAS and AD contributed to the development of the protocol, critical revision of the manuscript for important intellectual content. All authors read and approved the final manuscript
Acknowledgment
We would like to thank the Data Safety Monitoring Board Chair and members:
Michelle Ng Gong, M.D, M.S.(Chair)
Professor of Medicine
Professor of Epidemiology and Population Health
Albert Einstein College of Medicine
Chief, Department of Medicine Division of Critical Care
Chief, Department of Medicine Division of Pulmonary Medicine
Director, Department of Medicine Critical Care Research
Montefiore Medical Center, Bronx, NY, United States of America
Manpreet Singh Mundi, MD (Member)
Professor, Department of Medicine,
Division of Endocrinology, Diabetes, Metabolism, and Nutrition
Mayo Clinic, Rochester, MN
United States of America
Christopher John Lindsell (Member)
Professor of Biostatistics and Biomedical Informatics
Director, Vanderbilt Institute for Clinical and Translational Research (VICTR) Methods Program
Co-director, Vanderbilt Health Data Science (HEADS) Center
Nashville Tennessee
United States of America
Collaborators
The Saudi Critical Care Trials Group
King Abdulaziz Medical City, Riyadh: Yaseen M. Arabi, Hasan M. Al-Dorzi, Abdulaziz Al-Dawood, Omar Al Dibaasi, Jesna Jose, Musharaf Sadat, Haifa AlHumedi, Amal Almatroud
Brintha Naidu, Vicki Burrow, Salha Al Zayer, Haseena Banu Khan, Afonso Varela, Maram Sakkijha, Norah Khalid Alamrey, Hatim Areshi, Samah Qahtani, Amro Ghazi, Mohammed Moneer Hejazy
King Saud Medical City, Riyadh: Dina Muharib, Ahmed Mady, Mohammed AlAqeely
Maha AlOtaibi, Mohamed Ali Alodat, Rayan Alshayeh, AbdulRehman AlHarthi, Naif Al Qahtani, Yasmeen Ayed AlHejiely, Mada Muzhir AlZahrani, Mohammed Haddad Lhmdi, Nouf AlBakhiet
Katrina Baguisa, Huda Mhawish
King Abdulaziz university hospital, Jeddah: Haifa AlGhethamy, Saleh T Baaziz, Abeer Othman Azhar, Sara Fahad Alabbas, Liyakat Khan, Moataz Gabr, Shehla Nuzhat
King Abdulaziz Medical City, Jeddah: Dr. Fahad Al-Hameed, Dr. Gulam Rasool, Ohoud Al Orabi, Raghad Malabari, Kholoud Shobragi, Shaymaa Asaas
Prince Sultan Military Medical City: Adnan AlGhamdi, Ghaleb A. AlMekhlafi, Rabeah Hamad Alhutail, Madiha ElGhannam, Beverly Bcuizon, Bander AlAnezi, Christine Joy Anaud
Assir Central Hospital, Abha: Ali Al Bshabshe, Munir AlDammad, Yahia Otaif, Osama Hakami
King Abdulaziz Hospital, Ahsa: Jamal Chalabi, Arwa AlHusseini, Shahinaz Bashir
King Fahad Medical City: Dr. Mohammed Almaani
King Faisal Specialist Hospital and Research Center, Jeddah: Khalid Al Ghamdi, Lama Hefni
Samahar Alamoudi, Milyn L Ansing
King Faisal Specialist Hospital and Research Center, Riyadh: Khalid Maghrabi, Sawsan Albalawi, Manar Alahmadi, Mohammed AlHumaid, Samar Talal Nouri, Rozeena Huma
Khawla Farhan
Ohoud Hospital, Al-Madinah Al-Monawarah, Saudi Arabia: Ayman Kharaba, Mohamed Hussein, Kaouthar Sifaoui, Olfa Baji, Abdulrehman Alerw, Khloud Johani, Monera AlEnezi
Ismail Boudrar, Rabiah Atiq, Maali Junid, Maram Yusef
Al-Amiri Hospital, Ministry of Health, Kuwait : Abdulrahman A Al-Fares, Alia Al-Mutawa
Prince Mohammed bin Abdulaziz Hospital, Madinah, Saudi Arabia: Ahmad S Qureshi
Ahmed Quadri, Khalid Idrees
Jaber Al-Ahmed Al-Sabah Hospital Kuwait: Sarah Fadel Buabbas, Jumana Hani AlMubarak
King Saud University, Riyadh, Saudi Arabia: Rakan Alqahtani, Mona Bin Mabkoot
Jaber Al-Ahmed Al-Sabah Hospital, Kuwait: Sarah Adel Buabbas, Jumanna AlMubarak
Prince Mohammed bin Abdulaziz hospital, Riyadh, Saudi Arabia: Wadiah Alawi Al Filfil, Wafa Mansoor M Hazem, AbdulRehman Fahad alkraidees,
King Fahad Hospital of the University, Imam Abdulrahman Bin Faisal University, Al Khobar, Kingdom of Saudi Arabia: Mohammed S. Alshahrani, Talal Albrahim, Laila Perlas Asonto
Erasme University Hospital, Brussels, Belgium: Jean-Charles Preiser
University of Tartu, Estonia: Joel Starkopf
University of Copenhagen, Denmark: Anders Perner