- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03631927
Second Survey of Intensive Care in India (INDICAPS-II)
Indian Intensive Care Case Mix and Practice Patterns Study - II
INDICAPS was the first large scale, multicentre survey launched by the ISCCM. The aim was to gather information about ICUs, organizational characteristics, patient casemix, the types and severity of illness, monitoring and therapeutic modalities used, types of infections, and other such data. This was performed between July 2010 and April 2011 and published in 2016.[1] Over the last 8 years, there has been a significant difference in the delivery of intensive care services, critical care education, socioeconomic indicators, antibiotic resistance patterns and other aspects of practices in Indian ICUs. It is therefore necessary to revisit and resurvey the current trends in intensive care practices in India, and to reflect the vast spectrum of critical care illness, services and practices.
Similar to INDICAPS, which was a point-prevalence study of all patients present in the ICU on four different days over a one-year period, INDICAPS II will record data of all patients admitted to the ICU on 4 different days.
Přehled studie
Detailní popis
INDICAPS II will record data of all patients admitted to the ICU on 4 different days (August 23, 2018; October 25, 2018; December 13, 2018; April 11, 2019) in a cross-sectional design. Data collection includes:
- On admission: demographic characteristics, comorbidities, source of admission, primary and secondary admission diagnoses,
- Baseline data (on the study day), including parameters used to calculate SAPS II score and SOFA score and infections,
- Information on monitoring modalities, mechanical ventilation, nutrition, fluid therapy, other routine ICU practices
c. Outcome at ICU and hospital discharge d. Organisation of ICU services
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Delhi, Indie, 110070
- Fortis
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Andhra Pradesh
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Guntur, Andhra Pradesh, Indie, 522503
- Nri Medical College & General Hospital
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Visakhapatnam, Andhra Pradesh, Indie, 530002
- Care Hospitals
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Visakhapatnam, Andhra Pradesh, Indie, 530003
- Sevenhills Hospital
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Assam
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Guwahati, Assam, Indie, 781006
- Nemcare Hospital
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Guwahati, Assam, Indie, 781009
- Apollo Hospitals
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Guwahati, Assam, Indie, 781035
- Ayursundra Superspecialty hospital
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Bihar
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Patna, Bihar, Indie, 800014
- Paras Hmri Hospital
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Patna, Bihar, Indie, 801505
- All India Institute of Medical Sciences,Patna
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Delhi
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Gurgaon, Delhi, Indie, 122002
- Narayana Super Speciality Hospital
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Mathura, Delhi, Indie, 281001
- Nayati Medecity
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New Delhi, Delhi, Indie, 110076
- Indraprastha Apollo Hospitals
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New Delhi, Delhi, Indie, 110017
- Pushpawati Singhania Research Institute
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New Delhi, Delhi, Indie, v
- Blk Superspeciality Hospital
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Gujarat
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Ahmedabad, Gujarat, Indie, 380006
- HCG Hospitals
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Ahmedabad, Gujarat, Indie, 380052
- Sterling Hospital
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Ahmedabad, Gujarat, Indie, 380060
- CIMS Hospital
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Ahmedabad, Gujarat, Indie, 382428
- Apollo Hospital International Ltd
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Anand, Gujarat, Indie, 388325
- Shree Krishna Hospital
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Morbi, Gujarat, Indie, 363641
- Mangalam hospital
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Rajkot, Gujarat, Indie, 360005
- Shree Giriraj Multispeciality Hospital
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Rajkot, Gujarat, Indie, 360005
- Synergy Superspeciality Hospital
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Vadodara, Gujarat, Indie, 390011
- Spandan Multispeciality Hospital
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Vadodara, Gujarat, Indie, 390021
- GMERS Gotri Medical college
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Vadodara, Gujarat, Indie, 391760
- Dhiraj hospital SBKSMIRC
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Haryana
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Faridabad, Haryana, Indie, 121001
- Asian Institute of Medical sciences
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Gurgaon, Haryana, Indie, 122001
- Artemis Health Institute
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Gurgaon, Haryana, Indie, 122001
- Medanta - The Medicity
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Gurgaon, Haryana, Indie, 122001
- Medanta The Medicity
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Jammu And Kashmir
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Jammu, Jammu And Kashmir, Indie, 180019
- ASCOMS
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Karnataka
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Bangalore, Karnataka, Indie, 560034
- St John's Medical College Hospital
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Bengaluru, Karnataka, Indie, 560004
- Sri Shankara Cancer Hospital and Research Center
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Bengaluru, Karnataka, Indie, 560067
- Manipal hospital Whitefield
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Bengaluru, Karnataka, Indie
- Narayana Hrudayalaya
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Bijapur, Karnataka, Indie, 586109
- Shri Ganpatlal Agarwal Memorial Ayush Multi-specialty Hospital and Research Center
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Kerala
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Kochi, Kerala, Indie, 682027
- Aster Medcity
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Thodupuzha, Kerala, Indie, 685605
- Holy Family Hospital
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Madhya Pradesh
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Bhopal, Madhya Pradesh, Indie, 462030
- Chirayu Medical College and Hospital Bhopal
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Indore, Madhya Pradesh, Indie, 452014
- Choithram Hospital and Research Centre
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Rewa, Madhya Pradesh, Indie, 486001
- Chirayu Hospital
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Sagar, Madhya Pradesh, Indie, 470002
- Sagar shree hospital
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Maharashtra
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Akola, Maharashtra, Indie, 444001
- Ozone Multispeciality Hospital
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Aurangabad, Maharashtra, Indie, 431003
- MGM MCRI and Hospital
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Chiplun, Maharashtra, Indie, 415606
- BKL Walawalkar Rural Medical College & Hospital
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Kalyan, Maharashtra, Indie, 421204
- Fortis Hospitals Kalyan
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Mumbai, Maharashtra, Indie, 400012
- Tata Memorial Hospital
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Mumbai, Maharashtra, Indie, 400004
- Sir H N Reliance Foundation Hospital
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Mumbai, Maharashtra, Indie, 400016
- S L Raheja Hospital
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Mumbai, Maharashtra, Indie, 400017
- P.D.Hinduja National Hospital and M.R.C.
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Mumbai, Maharashtra, Indie, 400020
- Bombay Hospital Institute of Medical Sciences
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Mumbai, Maharashtra, Indie, 400026
- Breach Candy Hospital
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Mumbai, Maharashtra, Indie, 400026
- Jaslok Hospital
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Mumbai, Maharashtra, Indie, 400050
- Lilavati Hospital And Research Centre
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Mumbai, Maharashtra, Indie, 400056
- Nanavati Hospital
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Mumbai, Maharashtra, Indie, 400058
- Tata Memorial Hospital
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Mumbai, Maharashtra, Indie, 400076
- Dr. L. H. Hiranandani Hospital
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Nagpur, Maharashtra, Indie, 440010
- Suretech Hospital
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Nagpur, Maharashtra, Indie
- Criticare Hospital & Reaserch Institute
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Nagpur, Maharashtra, Indie
- Meditrina Institute of Medical Sciences
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Nashik, Maharashtra, Indie, 422003
- Apollo Hospitals
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Nashik, Maharashtra, Indie, 422004
- Ashoka Medicover hospital
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Navi Mumbai, Maharashtra, Indie
- Apollo Hospitals
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Nerul, Maharashtra, Indie, 400706
- Terna Speciality Hospital and Research Centre
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Pune, Maharashtra, Indie, 411004
- Deenanath Mangeshkar Hospital
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Pune, Maharashtra, Indie, 411001
- Ruby Hall Clinic
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Pune, Maharashtra, Indie, 411004
- Galaxy care hospital
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Pune, Maharashtra, Indie, 411004
- Sanjeevan Hospital
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Pune, Maharashtra, Indie, 411019
- Niramaya Hospital
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Pune, Maharashtra, Indie, 411040
- Ruby Hall Clinic Wanowrie
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Pune, Maharashtra, Indie, 411043
- Bharati Vidyapeeth (Deemed to be) University Medical College
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Solapur, Maharashtra, Indie, 413001
- Balwant institute of neurosurgery and intensive trauma care
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Orissa
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Bargarh, Orissa, Indie, 768028
- Vikash Multispecialty Hospital
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Bhubaneswar, Orissa, Indie, 751003
- IMS & SUM Hospital
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Bhubaneswar, Orissa, Indie, 751005
- Apollo Hospitals
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Bhubaneswar, Orissa, Indie, 751030
- AMRI Hospital
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Cuttack, Orissa, Indie, 753014
- Ashwini Hospital
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Punjab
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Ludhiana, Punjab, Indie, 141001
- Dayanand Medical College & Hospital
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Ludhiana, Punjab, Indie, 141003
- MICU, Deep Hospital
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Mohali, Punjab, Indie, 160062
- Fortis Hospital
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Rajasthan
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Bikaner, Rajasthan, Indie, 334004
- Kothari Medical and Research Institute
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Jaipur, Rajasthan, Indie, 302004
- Santokba Durlabhji Memorial Hospital
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Jaipur, Rajasthan, Indie, 302017
- Eternal Hospital
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Jaipur, Rajasthan, Indie, 302017
- JNU Institue of Medical Sciences and Reserach Center
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Jaipur, Rajasthan, Indie, 302021
- Shubh Hospital
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Tamilnadu
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Chennai, Tamilnadu, Indie, 600006
- Apollo Hospitals
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Chennai, Tamilnadu, Indie, 600030
- Billroth hospital
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Chennai, Tamilnadu, Indie
- Saveetha Medical College and hospital
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Vellore, Tamilnadu, Indie, 632004
- Christian Medical College
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Telangana
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Hyderabad, Telangana, Indie, 500008
- vsunshine hospitals, Gachibowli
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Hyderabad, Telangana, Indie, 500024
- Thumbay Hospital
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Hyderabad, Telangana, Indie, 500032
- Continental Hospitals
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Hyderabad, Telangana, Indie, 500034
- Basavatarakam Indo American Cancer Hospital and Research Institute
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Hyderabad, Telangana, Indie, 500034
- Century Super Specialty Hospital
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Hyderabad, Telangana, Indie, 500034
- Virinchi Hospital
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Hyderabad, Telangana, Indie
- Care Hospital Banjara Hills
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Uttar Pradesh
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Agra, Uttar Pradesh, Indie, 282002
- Pushpanjali Hospital
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Agra, Uttar Pradesh, Indie, 282007
- Synergy plush hospital
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Bareilly, Uttar Pradesh, Indie, 243202
- Medical ICU
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Bareilly, Uttar Pradesh, Indie, 243202
- Shri Ram Murti Smarak Institute of Medical Sciences
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Noida, Uttar Pradesh, Indie, 201301
- Fortis Hospital
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Noida, Uttar Pradesh, Indie, 201304
- Jaypee Hospital
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Varanasi, Uttar Pradesh, Indie, 221005
- Institute of Medical Sciences
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Uttarakhand
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Dehradun, Uttarakhand, Indie, 248001
- Max Superspeciality Hospital
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West Bengal
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Durgapur, West Bengal, Indie, 713206
- Iq City Medical College and Narayana Multi-Specialty Hospital
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Kolkata, West Bengal, Indie, 700099
- Medica Superspecialty Hospital
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Kolkata, West Bengal, Indie, 700054
- Apollo Gleneagles Hospital
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Kolkata, West Bengal, Indie, 700094
- Peerless Hospital
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Kolkata, West Bengal, Indie, 700098
- AMRI Hospitals Salt Lake
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Kolkata, West Bengal, Indie, 700099
- AMRI Hospitals
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- All patients present in the ICU on August 23, 2018; October 25, 2018; December 13, 2018; April 11, 2019
Exclusion Criteria:
- None
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: Jiný
- Časové perspektivy: Průřezový
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
---|---|
Patient
Patients admitted to participating ICUs on the specified dates
|
Pozorování
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
ICU Mortality
Časové okno: 30 days from the study day
|
Number of patients who died in the ICU, as well as those terminally discharged from the ICU
|
30 days from the study day
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Hospital Mortality
Časové okno: 30 days from the study day
|
all cause hospital mortality, including those terminally discharged from the ICU
|
30 days from the study day
|
ICU Length of Stay
Časové okno: upto 30 days from the study day
|
length of stay in the intensive care unit
|
upto 30 days from the study day
|
Hospital Length of Stay
Časové okno: upto 30 days from the study day
|
length of stay in the hospital
|
upto 30 days from the study day
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Studijní židle: Jigeeshu V Divatia, MD, FCCM, Tata Memorial Hospital
Publikace a užitečné odkazy
Obecné publikace
- Divatia JV, Amin PR, Ramakrishnan N, Kapadia FN, Todi S, Sahu S, Govil D, Chawla R, Kulkarni AP, Samavedam S, Jani CK, Rungta N, Samaddar DP, Mehta S, Venkataraman R, Hegde A, Bande BD, Dhanuka S, Singh V, Tewari R, Zirpe K, Sathe P; INDICAPS Study Investigators. Intensive Care in India: The Indian Intensive Care Case Mix and Practice Patterns Study. Indian J Crit Care Med. 2016 Apr;20(4):216-25. doi: 10.4103/0972-5229.180042.
- Divatia JV, Mehta Y, Govil D, Zirpe K, Amin PR, Ramakrishnan N, Kapadia FN, Sircar M, Sahu S, Bhattacharya PK, Myatra SN, Samavedam S, Dixit S, Pande RK, Mehta SN, Venkataraman R, Bajan K, Kumar V, Harne R, Thakur L, Rathod D, Sathe P, Gurav S, D'Silva C, Pasha SA, Todi SK. Intensive Care in India in 2018-2019: The Second Indian Intensive Care Case Mix and Practice Patterns Study. Indian J Crit Care Med. 2021 Oct;25(10):1093-1107. doi: 10.5005/jp-journals-10071-23965.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- INDICAPS2
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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