Clinical trial NCT04361838: The COVID-19 ICU PRAYER Study
Official title: Impact of Multi-Denominational Prayer on Morbidity and Mortality of Patients Admitted to the Intensive Care Unite With Corona Virus Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronavirus Infection
Lead sponsor: Kansas City Heart Rhythm Institute
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a multicenter; double blind randomized controlled study investigating the role of remote intercessory multi-denominational prayer on clinical outcomes in COVID-19 + patients in the intensive care unit. All patients enrolled will be randomized to use of prayer vs. no prayer in a 1:1 ratio. Each patient randomized to the prayer arm will receive a "universal" prayer offered by 5 religious denominations (Christianity, Hinduism, Islam, Judaism and Buddhism) in addition to standard of care. Whereas the patients randomized to the control arm will receive standard of care outlined by their medical teams. During ICU stay, patients will have serial assessment of multi-organ function and APACHE-II/SOFA scores serial evaluation performed on a daily basis until discharge. Data assessed include those listed below.


Eligibility criteria: Inclusion Criteria:

* Male or female greater than 18 years of age
* Confirmed positive for COVID-19
* Patient admitted to Intensive Care Unit

Exclusion Criteria:

* Patients admitted to ICU for diagnosis that is not COVID-19 positive.

Primary outcomes:
measure: Impact of multi-denominational prayer on clinical outcomes of critically ill COVID-19 patients in the Intensive Care Unit on mortality.
timeFrame: daily until patient recovers and moves out of ICU or exits the study, up to 30 days
Secondary outcomes:
measure: Difference in patient outcomes - Acute Physiology and Chronic Health Enquiry. APACHE II score.
timeFrame: daily until patient recovers and moves out of ICU or exits the study, up to 30 days.
measure: Difference in patient outcomes - Sequential Organ Failure Assessment - SOFA Score
timeFrame: daily until patient recovers and moves out of ICU or exits the study, up to 30 days
measure: Difference in patient outcomes - Length of stay in ICU.
timeFrame: daily until patient recovers and moves out of ICU or exits the study, up to 30 days
measure: Difference in patient outcomes - Length of ventilator support
timeFrame: daily until patient recovers and moves out of ICU or exits the study, up to 30 days
measure: Difference in patient outcomes - length of vasopressor support
timeFrame: daily until patient recovers and moves out of ICU or exits the study, up to 30 days
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Research Medical Center
state: Missouri
Study officials:
affiliation: Kansas City Heart Rhythm Institute
name: Dhanunjaya Lakkireddy, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Byrd RC. Positive therapeutic effects of intercessory prayer in a coronary care unit population. South Med J. 1988 Jul;81(7):826-9. doi: 10.1097/00007611-198807000-00005.
citation: Harris WS, Gowda M, Kolb JW, Strychacz CP, Vacek JL, Jones PG, Forker A, O'Keefe JH, McCallister BD. A randomized, controlled trial of the effects of remote, intercessory prayer on outcomes in patients admitted to the coronary care unit. Arch Intern Med. 1999 Oct 25;159(19):2273-8. doi: 10.1001/archinte.159.19.2273.
citation: Lakkireddy D, Vacek J, Harris W, Gowda M, Pendyala K, Murray C. Modified Mid America Heart Institute Coronary Care Unit scoring system--a new comprehensive prognostic index for Coronary Care Unit patients. Med Sci Monit. 2005 Mar;11(3):CR95-9.
citation: Jentzer JC, Bennett C, Wiley BM, Murphree DH, Keegan MT, Gajic O, Wright RS, Barsness GW. Predictive Value of the Sequential Organ Failure Assessment Score for Mortality in a Contemporary Cardiac Intensive Care Unit Population. J Am Heart Assoc. 2018 Mar 10;7(6):e008169. doi: 10.1161/JAHA.117.008169.
citation: Yoon JC, Kim YJ, Lee YJ, Ryoo SM, Sohn CH, Seo DW, Lee YS, Lee JH, Lim KS, Kim WY. Serial evaluation of SOFA and APACHE II scores to predict neurologic outcomes of out-of-hospital cardiac arrest survivors with targeted temperature management. PLoS One. 2018 Apr 5;13(4):e0195628. doi: 10.1371/journal.pone.0195628. eCollection 2018.
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