Critical IllnessINDICAPS-IINCT03631927
Second Survey of Intensive Care in India
An observational study of Critical Illness, run by Indian Society of Critical Care Medicine at 109 sites in India.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Critical Illness
- What is being tested?
- Observation
- How many people
- 5,094 participants
- Where
- 109 sitesIndia
- Study dates
- 23 Aug 2018to 11 May 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients present in the ICU on August 23, 2018; October 25, 2018; December 13, 2018; April 11, 2019
Who may be able to join
- All patients present in the ICU on August 23, 2018; October 25, 2018; December 13, 2018; April 11, 2019
Who cannot join
- None
Trial locations and contacts
109 sites in 1 country.
109 sites in 1 country
India109 sites
Pushpanjali Hospital
Agra, Uttar Pradesh, 282002
Synergy plush hospital
Agra, Uttar Pradesh, 282007
Hcg Hospitals
Ahmedabad, Gujarat, 380006
Sterling hospital
Ahmedabad, Gujarat, 380052
CIMS Hospital
Ahmedabad, Gujarat, 380060
Apollo Hospital International Ltd
Ahmedabad, Gujarat, 382428
Ozone Multispeciality Hospital
Akola, Maharashtra, 444001
Shree Krishna Hospital
Anand, Gujarat, 388325
St John's Medical College Hospital
Bangalore, Karnataka, 560034
Medical ICU
Bareilly, Uttar Pradesh, 243202
Shri Ram Murti Smarak Institute of Medical Sciences
Bareilly, Uttar Pradesh, 243202
Vikash Multispecialty Hospital
Bargarh, Odisha, 768028
Sri Shankara Cancer Hospital and Research Center
Bengaluru, Karnataka, 560004
Manipal hospital Whitefield
Bengaluru, Karnataka, 560067
Narayana Hrudayalaya
Bengaluru, Karnataka
Chirayu Medical College and Hospital Bhopal
Bhopal, Madhya Pradesh, 462030
Ims & Sum Hospital
Bhubaneswar, Odisha, 751003
Apollo Hospitals
Bhubaneswar, Odisha, 751005
AMRI Hospital
Bhubaneswar, Odisha, 751030
Kothari Medical and Research Institute
Bikaner, Rajasthan, 334004
Apollo Hospitals
Chennai, Tamil Nadu, 600006
Billroth hospital
Chennai, Tamil Nadu, 600030
Saveetha Medical College and Hospital
Chennai, Tamil Nadu
MGM MCRI and Hospital
Chhatrapati Sambhajinagar, Maharashtra, 431003
BKL Walawalkar Rural Medical College & Hospital
Chiplūn, Maharashtra, 415606
Ashwini Hospital
Cuttack, Odisha, 753014
Max Superspeciality Hospital
Dehradun, Uttarakhand, 248001
Fortis
Delhi, 110070
Iq City Medical College and Narayana Multi-Specialty Hospital
Durgapur, West Bengal, 713206
Asian Institute of Medical Sciences
Faridabad, Haryana, 121001
Nri Medical College & General Hospital
Guntur, Andhra Pradesh, 522503
Artemis Health Institute
Gurgaon, Haryana, 122001
Medanta - The Medicity
Gurgaon, Haryana, 122001
Medanta The Medicity
Gurgaon, Haryana, 122001
Narayana Super Speciality Hospital
Gurgaon, National Capital Territory of Delhi, 122002
Nemcare Hospital
Guwahati, Assam, 781006
Apollo hospitals
Guwahati, Assam, 781009
Ayursundra superspecialty Hospital
Guwahati, Assam, 781035
vsunshine hospitals, Gachibowli
Hyderabad, Telangana, 500008
Thumbay Hospital
Hyderabad, Telangana, 500024
Continental Hospitals
Hyderabad, Telangana, 500032
Basavatarakam Indo American Cancer Hospital and Research Institute
Hyderabad, Telangana, 500034
Century Super Specialty Hospital
Hyderabad, Telangana, 500034
Virinchi Hospital
Hyderabad, Telangana, 500034
Care Hospital Banjara Hills
Hyderabad, Telangana
Choithram hospital and research centre
Indore, Madhya Pradesh, 452014
Santokba Durlabhji Memorial Hospital
Jaipur, Rajasthan, 302004
Eternal Hospital
Jaipur, Rajasthan, 302017
JNU Institue of Medical Sciences and Reserach Center
Jaipur, Rajasthan, 302017
Shubh Hospital
Jaipur, Rajasthan, 302021
ASCOMS
Jammu, Jammu and Kashmir, 180019
Fortis Hospitals Kalyan
Kalyān, Maharashtra, 421204
Aster Medcity
Kochi, Kerala, 682027
Apollo Gleneagles Hospital
Kolkata, West Bengal, 700054
Peerless Hospital
Kolkata, West Bengal, 700094
AMRI Hospitals Salt Lake
Kolkata, West Bengal, 700098
Amri Hospitals
Kolkata, West Bengal, 700099
Medica Superspecialty Hospital
Kolkata, West Bengal, 700099
Dayanand Medical College & Hospital
Ludhiana, Punjab, 141001
MICU, Deep Hospital
Ludhiana, Punjab, 141003
Nayati Medecity
Mathura, National Capital Territory of Delhi, 281001
Fortis Hospital
Mohali, Punjab, 160062
Mangalam hospital
Morvi, Gujarat, 363641
Sir H N Reliance Foundation Hospital
Mumbai, Maharashtra, 400004
Tata Memorial Hospital
Mumbai, Maharashtra, 400012
S L Raheja Hospital
Mumbai, Maharashtra, 400016
P.D.Hinduja National Hospital and M.R.C.
Mumbai, Maharashtra, 400017
Bombay Hospital Institute of Medical Sciences
Mumbai, Maharashtra, 400020
Breach Candy Hospital
Mumbai, Maharashtra, 400026
Jaslok Hospital
Mumbai, Maharashtra, 400026
Lilavati Hospital and Research Centre
Mumbai, Maharashtra, 400050
Nanavati Hospital
Mumbai, Maharashtra, 400056
Tata Memorial Hospital
Mumbai, Maharashtra, 400058
Dr. L. H. Hiranandani Hospital
Mumbai, Maharashtra, 400076
Suretech Hospital
Nagpur, Maharashtra, 440010
Criticare Hospital & Reaserch Institute
Nagpur, Maharashtra
Meditrina Institute of Medical Sciences
Nagpur, Maharashtra
Apollo Hospitals
Nashik, Maharashtra, 422003
Ashoka Medicover hospital
Nashik, Maharashtra, 422004
Apollo Hospitals
Navi Mumbai, Maharashtra
Terna Speciality Hospital and Research Centre
Nerul, Maharashtra, 400706
Pushpawati Singhania Research Institute
New Delhi, National Capital Territory of Delhi, 110017
Indraprastha Apollo Hospitals
New Delhi, National Capital Territory of Delhi, 110076
BLK Superspeciality Hospital
New Delhi, National Capital Territory of Delhi, v
Fortis Hospital
Noida, Uttar Pradesh, 201301
Jaypee Hospital
Noida, Uttar Pradesh, 201304
Paras Hmri Hospital
Patna, Bihar, 800014
All India Institute of Medical Sciences,Patna
Patna, Bihar, 801505
Ruby Hall Clinic
Pune, Maharashtra, 411001
Deenanath Mangeshkar Hospital
Pune, Maharashtra, 411004
Galaxy care hospital
Pune, Maharashtra, 411004
Sanjeevan Hospital
Pune, Maharashtra, 411004
Niramaya Hospital
Pune, Maharashtra, 411019
Ruby Hall Clinic Wanowrie
Pune, Maharashtra, 411040
Bharati Vidyapeeth (Deemed to be) University Medical College
Pune, Maharashtra, 411043
Shree Giriraj Multispeciality Hospital
Rajkot, Gujarat, 360005
Synergy Superspeciality Hospital
Rajkot, Gujarat, 360005
Chirayu hospital
Rewa, Madhya Pradesh, 486001
Sagar shree hospital
Sāgar, Madhya Pradesh, 470002
Balwant institute of neurosurgery and intensive trauma care
Solapur, Maharashtra, 413001
Holy Family Hospital
Thodupuzha, Kerala, 685605
Spandan Multispeciality Hospital
Vadodara, Gujarat, 390011
GMERS Gotri Medical college
Vadodara, Gujarat, 390021
Dhiraj hospital SBKSMIRC
Vadodara, Gujarat, 391760
Institute of Medical Sciences
Varanasi, Uttar Pradesh, 221005
Christian Medical College
Vellore, Tamil Nadu, 632004
Shri Ganpatlal Agarwal Memorial Ayush Multi-specialty Hospital and Research Center
Vijayapura, Karnataka, 586109
CARE Hospitals
Visakhapatnam, Andhra Pradesh, 530002
Sevenhills Hospital
Visakhapatnam, Andhra Pradesh, 530003
About this study
Official title: 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.
Read the detailed description
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
- Outcome at ICU and hospital discharge d. Organisation of ICU services
- Conditions
- Critical Illness
- Being tested
- Observation
- Keywords
- critical care unit
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Observation
| Study group | Role | What they receive |
|---|---|---|
| Patient | Patients admitted to participating ICUs on the specified dates Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU Mortality
Number of patients who died in the ICU, as well as those terminally discharged from the ICU
Measured: 30 days from the study day
Secondary outcomes (3)
Hospital Mortality
all cause hospital mortality, including those terminally discharged from the ICU
Measured: 30 days from the study day
ICU Length of Stay
length of stay in the intensive care unit
Measured: upto 30 days from the study day
Hospital Length of Stay
length of stay in the hospital
Measured: upto 30 days from the study day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start23 Aug 2018
- Primary completion11 Apr 2019
- Study completion11 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 5,094 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indian Society of Critical Care Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jigeeshu V Divatia, MD, FCCM, Study chair, Tata Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631927
- Sponsor's protocol ID
- INDICAPS2
- Acronym
- INDICAPS-II
- Status last verified
- Nov 2021
- First submitted
- 13 Aug 2018
- Last updated
- 11 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27186054Divatia 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; the INDICAPS-II investigators. 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.
PubMed 34916740
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indian Intensive Care Case Mix and Practice Patterns Study - II
- ClinicalTrials.gov ID
- NCT03631927
- Acronym / sponsor ID
- INDICAPS-II / INDICAPS2
- Conditions
- Critical Illness
- Keywords
- critical care unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,094 participants (actual)
- Lead sponsor
- Indian Society of Critical Care MedicineUniversity, hospital or other
- Study start
- 23 Aug 2018 (actual)
- Primary completion
- 11 Apr 2019 (actual)
- Study completion
- 11 May 2019 (actual)
- First posted
- 15 Aug 2018 (actual)
- Results
- Posted 11 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- Outcome at ICU and hospital discharge d. Organisation of ICU services
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Other: ObservationPatients admitted to participating ICUs on the specified dates |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients present in the ICU on August 23, 2018; October 25, 2018; December 13, 2018; April 11, 2019
Key inclusion criteria (1 listed)
- All patients present in the ICU on August 23, 2018; October 25, 2018; December 13, 2018; April 11, 2019
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationObservation | Other | Patient |
Primary outcome
ICU Mortality
Time frame: 30 days from the study day
Number of patients who died in the ICU, as well as those terminally discharged from the ICU
3 secondary outcomes
Hospital Mortality
Time frame: 30 days from the study day
ICU Length of Stay
Time frame: upto 30 days from the study day
Hospital Length of Stay
Time frame: upto 30 days from the study day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27186054Divatia 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.
- Derived from this study: PubMed 34916740Divatia 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; the INDICAPS-II investigators. 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.
- Individual participant dataSharing planned: No
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jigeeshu V Divatia, MD, FCCM study chair
Tata Memorial Hospital
109 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Indian Society of Critical Care Medicine at 109 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 109 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU Mortality (time frame: 30 days from the study day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03631927, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2021.