ABSTRACT
BackgroundSevere Corona virus disease (COVID-19) is associated with high mortality. Although single centre intensive care units (ICU) have reported clinical characteristics and outcomes, no large scale multicentric study from India has been published. The present retrospective, multi-centre study was aimed to describe the predictors and outcomes of COVID-19 patients requiring ICU admission from COVID-19 Registry of Indian council of Medical Research (ICMR), India.MethodsProspectively collected data from multiple participating institutions was entered in the electronic National Clinical Registry of COVID 19. We enrolled patients aged>18 years with COVID-19 pneumonia requiring ICU admission between March 2020 and August 2021. Exclusion criteria were negative RT PCR, death within 24 hours of ICU admission, or patients with incomplete data in the registry Their demographic characteristics, laboratory variables, ICU severity indices, treatment strategies and outcomes were analysed.ResultsA total of 5865 patients, with mean age 56±15 years, with 3840/5865 (65.4%) men, were enrolled in the ICMR registry.. Overall mortality was 2535/5865 (43.5%). Non-survivors were older than survivors (58.2±15.4 years vs 53.6 ±14.7 years; P=0.001). Non-survivors had multiple comorbidities (n=1951, 52.9%) with hypertension (47.2%) and diabetes (45.6%) being the most common, higher creatinine (1.6 ± P=0.001, high D-dimer (1.56 vs 1.37, P=0.001), higher CT severity index (16.8±5.2 vs 13.5 ±5.47 ) compared to survivors. Non survivors had longer hospital and ICU stay (P=0.001). On multivariate regression analysis, high NLR (HR 1.017, 95% CI 1.005- 1.029, P=0.001), high CRP (HR 1.008, 95% CI 1.006- 1.010, P=0.001), high D dimer ((HR 1.089, 95% CI 1.065- 1.113, P=0.001) were associated with mechanical ventilation while younger age, (HR 0.974, CI 0.965-0.983, p=0.001), high D dimer (HR-1.014, CI 1.001-1.027, P=0.035) and use of prophylactic LMWH (HR 0.647, CI 0.527-0.794, p=0.001) were independently associated with mortality. ConclusionIn this large retrospective study of 5865 critically ill COVID 19 patients admitted to ICU, overall mortality was 2535/5865 (43.5%). Age, high D dimer, CT Severity score and use of prophylactic LMWH were independently associated with mortality.
Subject(s)
COVID-19ABSTRACT
Condition:
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhereIntervention:
Intervention1: Shirashadi Kasai: Shirashadi Kasai (SK). It consists of 5 medicinal plants, namely Albizzia lebbeck, Solanum Xanthocarpum,Adhatodavasica, Glycyrrhiza glabra and Cinnamum tamal.
10 gm decoction, twice a day, through oral route
Control Intervention1: Standard care for COVID 19 patients as per Government of India advisory: Drugs advised by Government of India in its advisory for COVID 19 patients
Primary outcome:
In this study, Primary outcome will be the time to clinical improvement,defined as the time from randomization to either an improvement of two points on a seven category ordinal scale or discharge from the hospital, whichever came first.Timepoint: Daily until dischargeCriteria:
Inclusion criteria: 1. Subject (or legally authorized representative) provides written informed consent prior toinitiation of any study procedures.
2. Understands and agrees to comply with planned study procedures.
3. Agrees to the collection of OP swabs and venous blood per protocol.
4. Male or non-pregnant female adult >=18 years of age at time of enrolment.
5. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other
commercial or public health assay in any specimen < 72 hours prior to randomization.
6. Illness of any duration, and at least one of the following:
Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR
Clinical assessment (evidence of rales/crackles on exam) AND SpO2 <= 94%on room air, OR
Requiring mechanical ventilation and/or supplemental oxygen.
7. Women of childbearing potential must agree to use at least one primary form of
contraception for the duration of the study (acceptable methods will be determined by the
site).
Exclusion criteria: 1. ALT/AST > 5 times the upper limit of normal.
2. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30)
3. Pregnancy or breast feeding.
4. Anticipated transfer to another hospital which is not a study site within 72 hours.
5. Allergy to any study medication