- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat 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.
A tanulmány áttekintése
Részletes leírás
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
Tanulmány típusa
Beiratkozás (Tényleges)
Kapcsolatok és helyek
Tanulmányi helyek
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Delhi, India, 110070
- Fortis
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Andhra Pradesh
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Guntur, Andhra Pradesh, India, 522503
- Nri Medical College & General Hospital
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Visakhapatnam, Andhra Pradesh, India, 530002
- CARE Hospitals
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Visakhapatnam, Andhra Pradesh, India, 530003
- Sevenhills Hospital
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Assam
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Guwahati, Assam, India, 781006
- Nemcare Hospital
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Guwahati, Assam, India, 781009
- Apollo Hospitals
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Guwahati, Assam, India, 781035
- Ayursundra Superspecialty hospital
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Bihar
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Patna, Bihar, India, 800014
- Paras Hmri Hospital
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Patna, Bihar, India, 801505
- All India Institute of Medical Sciences,Patna
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Delhi
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Gurgaon, Delhi, India, 122002
- Narayana Super Speciality Hospital
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Mathura, Delhi, India, 281001
- Nayati Medecity
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New Delhi, Delhi, India, 110076
- Indraprastha Apollo Hospitals
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New Delhi, Delhi, India, 110017
- Pushpawati Singhania Research Institute
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New Delhi, Delhi, India, v
- Blk Superspeciality Hospital
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Gujarat
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Ahmedabad, Gujarat, India, 380006
- HCG Hospitals
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Ahmedabad, Gujarat, India, 380052
- Sterling Hospital
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Ahmedabad, Gujarat, India, 380060
- Cims Hospital
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Ahmedabad, Gujarat, India, 382428
- Apollo Hospital International Ltd
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Anand, Gujarat, India, 388325
- Shree Krishna Hospital
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Morbi, Gujarat, India, 363641
- Mangalam hospital
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Rajkot, Gujarat, India, 360005
- Shree Giriraj Multispeciality Hospital
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Rajkot, Gujarat, India, 360005
- Synergy Superspeciality Hospital
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Vadodara, Gujarat, India, 390011
- Spandan Multispeciality Hospital
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Vadodara, Gujarat, India, 390021
- GMERS Gotri Medical college
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Vadodara, Gujarat, India, 391760
- Dhiraj hospital SBKSMIRC
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Haryana
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Faridabad, Haryana, India, 121001
- Asian Institute of Medical sciences
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Gurgaon, Haryana, India, 122001
- Artemis Health Institute
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Gurgaon, Haryana, India, 122001
- Medanta - The Medicity
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Gurgaon, Haryana, India, 122001
- Medanta The Medicity
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Jammu And Kashmir
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Jammu, Jammu And Kashmir, India, 180019
- ASCOMS
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Karnataka
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Bangalore, Karnataka, India, 560034
- St John's Medical College Hospital
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Bengaluru, Karnataka, India, 560004
- Sri Shankara Cancer Hospital and Research Center
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Bengaluru, Karnataka, India, 560067
- Manipal hospital Whitefield
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Bengaluru, Karnataka, India
- Narayana Hrudayalaya
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Bijapur, Karnataka, India, 586109
- Shri Ganpatlal Agarwal Memorial Ayush Multi-specialty Hospital and Research Center
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Kerala
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Kochi, Kerala, India, 682027
- Aster Medcity
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Thodupuzha, Kerala, India, 685605
- Holy Family Hospital
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Madhya Pradesh
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Bhopal, Madhya Pradesh, India, 462030
- Chirayu Medical College and Hospital Bhopal
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Indore, Madhya Pradesh, India, 452014
- Choithram Hospital and Research Centre
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Rewa, Madhya Pradesh, India, 486001
- Chirayu Hospital
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Sagar, Madhya Pradesh, India, 470002
- Sagar shree hospital
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Maharashtra
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Akola, Maharashtra, India, 444001
- Ozone Multispeciality Hospital
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Aurangabad, Maharashtra, India, 431003
- MGM MCRI and Hospital
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Chiplun, Maharashtra, India, 415606
- BKL Walawalkar Rural Medical College & Hospital
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Kalyan, Maharashtra, India, 421204
- Fortis Hospitals Kalyan
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Mumbai, Maharashtra, India, 400012
- Tata Memorial Hospital
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Mumbai, Maharashtra, India, 400004
- Sir H N Reliance Foundation Hospital
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Mumbai, Maharashtra, India, 400016
- S L Raheja Hospital
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Mumbai, Maharashtra, India, 400017
- P.D.Hinduja National Hospital and M.R.C.
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Mumbai, Maharashtra, India, 400020
- Bombay Hospital Institute of Medical Sciences
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Mumbai, Maharashtra, India, 400026
- Breach Candy Hospital
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Mumbai, Maharashtra, India, 400026
- Jaslok Hospital
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Mumbai, Maharashtra, India, 400050
- Lilavati Hospital And Research Centre
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Mumbai, Maharashtra, India, 400056
- Nanavati Hospital
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Mumbai, Maharashtra, India, 400058
- Tata Memorial Hospital
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Mumbai, Maharashtra, India, 400076
- Dr. L. H. Hiranandani Hospital
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Nagpur, Maharashtra, India, 440010
- Suretech Hospital
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Nagpur, Maharashtra, India
- Criticare Hospital & Reaserch Institute
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Nagpur, Maharashtra, India
- Meditrina Institute of Medical Sciences
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Nashik, Maharashtra, India, 422003
- Apollo Hospitals
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Nashik, Maharashtra, India, 422004
- Ashoka Medicover hospital
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Navi Mumbai, Maharashtra, India
- Apollo Hospitals
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Nerul, Maharashtra, India, 400706
- Terna Speciality Hospital and Research Centre
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Pune, Maharashtra, India, 411004
- Deenanath Mangeshkar Hospital
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Pune, Maharashtra, India, 411001
- Ruby Hall Clinic
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Pune, Maharashtra, India, 411004
- Galaxy care hospital
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Pune, Maharashtra, India, 411004
- Sanjeevan Hospital
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Pune, Maharashtra, India, 411019
- Niramaya Hospital
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Pune, Maharashtra, India, 411040
- Ruby Hall Clinic Wanowrie
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Pune, Maharashtra, India, 411043
- Bharati Vidyapeeth (Deemed to be) University Medical College
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Solapur, Maharashtra, India, 413001
- Balwant institute of neurosurgery and intensive trauma care
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Orissa
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Bargarh, Orissa, India, 768028
- Vikash Multispecialty Hospital
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Bhubaneswar, Orissa, India, 751003
- IMS & SUM Hospital
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Bhubaneswar, Orissa, India, 751005
- Apollo Hospitals
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Bhubaneswar, Orissa, India, 751030
- AMRI Hospital
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Cuttack, Orissa, India, 753014
- Ashwini Hospital
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Punjab
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Ludhiana, Punjab, India, 141001
- Dayanand Medical College & Hospital
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Ludhiana, Punjab, India, 141003
- MICU, Deep Hospital
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Mohali, Punjab, India, 160062
- Fortis Hospital
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Rajasthan
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Bikaner, Rajasthan, India, 334004
- Kothari Medical and Research Institute
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Jaipur, Rajasthan, India, 302004
- Santokba Durlabhji Memorial Hospital
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Jaipur, Rajasthan, India, 302017
- Eternal Hospital
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Jaipur, Rajasthan, India, 302017
- JNU Institue of Medical Sciences and Reserach Center
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Jaipur, Rajasthan, India, 302021
- Shubh Hospital
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Tamilnadu
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Chennai, Tamilnadu, India, 600006
- Apollo Hospitals
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Chennai, Tamilnadu, India, 600030
- Billroth hospital
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Chennai, Tamilnadu, India
- Saveetha Medical College and hospital
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Vellore, Tamilnadu, India, 632004
- Christian Medical College
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Telangana
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Hyderabad, Telangana, India, 500008
- vsunshine hospitals, Gachibowli
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Hyderabad, Telangana, India, 500024
- Thumbay Hospital
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Hyderabad, Telangana, India, 500032
- Continental Hospitals
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Hyderabad, Telangana, India, 500034
- Basavatarakam Indo American Cancer Hospital and Research Institute
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Hyderabad, Telangana, India, 500034
- Century Super Specialty Hospital
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Hyderabad, Telangana, India, 500034
- Virinchi Hospital
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Hyderabad, Telangana, India
- Care Hospital Banjara Hills
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Uttar Pradesh
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Agra, Uttar Pradesh, India, 282002
- Pushpanjali Hospital
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Agra, Uttar Pradesh, India, 282007
- Synergy plush hospital
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Bareilly, Uttar Pradesh, India, 243202
- Medical ICU
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Bareilly, Uttar Pradesh, India, 243202
- Shri Ram Murti Smarak Institute of Medical Sciences
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Noida, Uttar Pradesh, India, 201301
- Fortis Hospital
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Noida, Uttar Pradesh, India, 201304
- Jaypee Hospital
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Varanasi, Uttar Pradesh, India, 221005
- Institute of Medical Sciences
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Uttarakhand
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Dehradun, Uttarakhand, India, 248001
- Max Superspeciality Hospital
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West Bengal
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Durgapur, West Bengal, India, 713206
- Iq City Medical College and Narayana Multi-Specialty Hospital
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Kolkata, West Bengal, India, 700099
- Medica Superspecialty Hospital
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Kolkata, West Bengal, India, 700054
- Apollo Gleneagles Hospital
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Kolkata, West Bengal, India, 700094
- Peerless Hospital
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Kolkata, West Bengal, India, 700098
- AMRI Hospitals Salt Lake
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Kolkata, West Bengal, India, 700099
- AMRI Hospitals
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Gyermek
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Tanulmányozható nemek
Mintavételi módszer
Tanulmányi populáció
Leírás
Inclusion Criteria:
- All patients present in the ICU on August 23, 2018; October 25, 2018; December 13, 2018; April 11, 2019
Exclusion Criteria:
- None
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Megfigyelési modellek: Egyéb
- Időperspektívák: Keresztmetszeti
Kohorszok és beavatkozások
Csoport / Kohorsz |
Beavatkozás / kezelés |
---|---|
Patient
Patients admitted to participating ICUs on the specified dates
|
Megfigyelés
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
ICU Mortality
Időkeret: 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
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
Hospital Mortality
Időkeret: 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
Időkeret: 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
Időkeret: upto 30 days from the study day
|
length of stay in the hospital
|
upto 30 days from the study day
|
Együttműködők és nyomozók
Nyomozók
- Tanulmányi szék: Jigeeshu V Divatia, MD, FCCM, Tata Memorial Hospital
Publikációk és hasznos linkek
Általános kiadványok
- 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.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- INDICAPS2
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .
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