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CTRI Number  CTRI/2023/04/051342 [Registered on: 06/04/2023] Trial Registered Prospectively
Last Modified On: 01/08/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Recovery in Acute Kidney failure developed in ICU: An observational study in multiple hospitals in India 
Scientific Title of Study   Renal recovery in hospital acquired AKI: A multicenter non intervention observational study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vivek Gupta 
Designation  Consultant 
Affiliation  Dayanand Medical College and Hospital Unit Hero DMC Heart Institute 
Address  Research & Development center Dayanand Medical college and Hospital Tagore Nagar Ludhiana
Department of Cardiac Anaesthesia Hero DMC Heart Institute Tagore Nagar Ludhiana
Ludhiana
PUNJAB
141001
India 
Phone  9815398993  
Fax  0161-2304289  
Email  dr_vivekg@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vivek Gupta 
Designation  Consultant 
Affiliation  Dayanand Medical College and Hospital Unit Hero DMC Heart Institute 
Address  Research and Development center Dayanand Medical College and Hospital Tagore Nagar Ludhiana
Department of Cardiac anaesthesia Hero DMC Heart Institute Tagore Nagar Ludhiana
Ludhiana
PUNJAB
141001
India 
Phone  9815398993  
Fax  0161-2304289  
Email  dr_vivekg@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vivek Gupta 
Designation  Consultant 
Affiliation  Dayanand Medical College and Hospital Unit Hero DMC Heart Institute 
Address  Research and Development center Dayanand Medical College and Hospital Tagore Nagar Ludhiana
Department of Cardiac Anaesthesia Hero DMC Heart Institute Tagore Nagar Ludhiana
Ludhiana
PUNJAB
141001
India 
Phone  9815398993  
Fax  0161-2304289  
Email  dr_vivekg@yahoo.com  
 
Source of Monetary or Material Support  
Indian Society of Critical Care Medicine 
 
Primary Sponsor  
Name  Indian Society of Critical Care Medicine 
Address  Unit 13 and 14 First Floor Hind Service Industries Premises Coop Society Near Chaitya Bhoomi Off Veer Savarkar Marg Dadar Mumbai 400028 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sharmili Sinha  Apollo Hospitals Bhubaneswar  Main building 3rd floor Quality Management System Office Plot no 251 Samantapuri sainik school road unit 15 bhubaneswar 751005
Gajapati
ORISSA 
9861550079

sharmili.sinha@yahoo.co.in 
Dr Vivek Gupta  Daynand Medical College and Hospital   Hero DMC Heart Institute Department of Cardiac ANaesthesia & Intensive Care Tagore Nagar Civil Lines Ludhiana
Ludhiana
PUNJAB 
0161-2304282
0161-2304289
dr_vivekg@yahoo.com 
Jyotsna Mali  Lata Mangeshkar Hospital  Digdoh road Hingna Road Nagpur 440019
Nagpur
MAHARASHTRA 
8097642773

jyo146@gmail.com 
Anil Kumar  Santosh Medical College & Hospital  sector-12 santosh nagar pratap vihar ghaziabad uttar pradesh
Ghaziabad
UTTAR PRADESH 
9818384955

dranilkumar22@hotmail.com 
Shubha sharma  Shrimann Superspeciality Hospital  Pathankot road near reru chowk jalandhar 1441012
Jalandhar
PUNJAB 
9814160983

docshubha63@gmail.com 
Revathi Aiyer  Sterling Hospital  4th floor, phase-1, opp. INOX, race course circle west vadodara 390007
Vadodara
GUJARAT 
9898610366

revathiaiyer@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 25  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE LATA MANGESHKAR HOSPITAL  Approved 
CRITICARE HOSPITAL & RESEARCH INSTITUTE ETHICS COMMITTEE  Approved 
DAYANAND MEDICAL COLLEGE AND HOSPITAL INSTITUTIONAL ETHICS COMMITTEE  Approved 
Human Care Medical Charitable Trust  Approved 
IEC ALL INDIA INSTITUTE OF MEDICAL SCIENCES, PATNA  Approved 
IEC APOLLO BGS HOSPITAL, MYSORE  Approved 
IEC INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES SHEIKHPURA  Approved 
IEC INSTITUTE OF MEDICAL SCIENCES (IMS) AND SUM HOSPITAL  Approved 
IEC SDM COLLEGE OF MEDICAL SCIENCES & HOSPITAL  Approved 
IEC YASHODA ACADEMY OF MEDICAL EDUCATION & RESEARCH  Approved 
IEC-BIOMEDICAL RESEARCH TAGORE HOSPITAL & HEART CARE CENTRE  Approved 
Institutional Ethics Committee Biomedical Research Apollo Hospitals Bhubneswar  Approved 
INSTITUTIONAL ETHICS COMMITTEE FORTIS ESCORTS, JAIPUR  Approved 
INSTITUTIONAL ETHICS COMMITTEE OF MAHATMA GANDHI MEDICAL COLLEGE & HOSPITAL  Approved 
INSTITUTIONAL ETHICS COMMITTEE OF MANIPAL HOSPITALS, BANGALORE  Approved 
INSTITUTIONAL ETHICS COMMITTEE OF SHER-I-KASHMIR INSTITUTE OF MEDICAL SCIENCES, SRINAGAR  Approved 
INSTITUTIONAL ETHICS COMMITTEE RIMS, RANCHI  Approved 
INSTITUTIONAL ETHICS COMMITTEE SHANTI MEMORIAL HOSPITAL  Approved 
INSTITUTIONAL ETHIS COMMITTEE FORTIS ESCORTS HOSPITAL AMRITSAR  Approved 
LALITHA SUPER SPECIALITIES HOSPITAL EC  Approved 
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEURO SCIENCES  Approved 
Punjab Institute of Medical Sciences Jalandhar  Approved 
Screening Committee of Santosh Medical College and Hospital  Approved 
SDM COLLEGE OF MEDICAL SCIENCES & HOSPITAL  Approved 
Sterling Ethics Committee Baroda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N17||Acute kidney failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  The patients who developed AKI after 48 hours hospitalization 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Survival and renal recovery after developing HAAKI  Discharge from hospital or 30 days from the day of HAAKI diagnosis, whichever is earlier 
 
Secondary Outcome  
Outcome  TimePoints 
• Pattern of HAAKI in various ICU (Staging, Risk factors, Etiological factor)
• Need of interventions besides correcting the underlying cause (Use of RRT/ Diuretic boluses or infusions)
 
Discharge from hospital or 30 days from the day of HAAKI diagnosis, whichever is earlier 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/05/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Background: Development of acute kidney injury (AKI) in hospitalized patients is associated with increased length of intensive care unit (ICU) stay, prolonged hospital stay as well as higher mortality and morbidity. 1,2,3 The incidence of AKI with various degree of severity ranges from 1–25% of ICU admission.4 The incidence of the disease seems to be increasing possibly due to a parallel increase in the number of elderly, more severely and chronically ill patients.5

 

Objective: To study the pattern of renal recovery in patient who developed AKI in hospital/ ICU.

Criteria for AKI: As per the KDIGO guidelines6

AKI is defined as any of the following:  Increase in SCr by X0.3 mg/dl (X26.5 lmol/l) within 48 hours; or Increase in SCr to X1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or Urine volume < 0.5 ml/kg/h for 6 hours.

Criteria for renal recovery6,7,8

·        Complete: Renal function returned to base line with adequate urine output/ No intervention required

·        Partial with no RRT: Decline in severity stage,Declining trend of creatinine,Renal dysfunction still existing with urine output> 500 ml/dayand no need of Renal replacement therapy.

·        Partial with RRT requirement: Urine output less than 500 ml/day and requiring RRT infrequently.

·        Non recovery with RRT dependent: Urine output<300 ml/day and planned for RRT on regular basis.

Method:Prospective observational study for a period 3 month (1st Sep 2022- 30 Nov 2022) will be performed in various ICU’s across the India. The data will be collected for 30 days or till discharge (whichever is earlier) from the date of AKI diagnosis.

Inclusion:All patients who developed AKI after 48 hour of hospital admission.

                 Age 18 years & above

Exclusion: CKD patients or any patient who has developed AKI prior to admission or within 48 hours

(However patient transferred from other health care facility with available records showing development of AKI within 48 hour of admission in the transferring hospital may be included in the study)

Nephrotoxic drugs: If a patient had received a drug with known nephrotoxic potential for a minimum period of two days prior to the defined increase in serum creatinine concentration.

Sepsis:9Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection.

Organ dysfunction can be identified as an acute change in total SOFA score ≥2 points consequent to the infection.

·        The baseline SOFA score can be assumed to be zero in patients not known to have pre-existing organ dysfunction.

·        A SOFA score ≥2 reflects an overall mortality risk of approximately 10% in a general hospital population with suspected infection. Even patients presenting with modest dysfunction can deteriorate further, emphasizing the seriousness of this condition and the need for prompt and appropriate intervention, if not already being instituted.

In lay terms, sepsis is a life-threatening condition that arises when the body’s response to an infection injures its own tissues and organs.

Hypotension:Systolic blood pressure BP <90 mm Hg, inspite of adequate fluid resuscitation

Hypovolemia: If there was obvious cause of volume depletion along with loss of skin turgor with decrease of more than 5% of body weight

 

 

Type of AKI

Possible Prerenal/ Renal/ Post Renal

            On clinical judgement of intensivist/ nephrologist

Confirmed Prerenal/Renal/ Postrenal(as per the clinical need on treating physician decision)

            Urine analysis (Blood/ Protein)

            Urinary Na/ Urinary Creatinine

            FENa

            USG Abdomen       

Primary outcome:

·        Survival and renal recovery after developing HAAKI

Secondary outcome

·        Pattern of HAAKI in various ICU (Staging, Risk factors, Aetiological factor)

·        Need of interventions besides correcting the underlying cause (Use of RRT/ Diuretic boluses or infusions)

Data collection:

·        Demographics

·        Date of Admission

·        Date of AKI diagnosis/ Grade or severity of AKI (note the worst)

·        Urine output: At admission/ at Diagnosis of AKI/ Worst value during the course/ at the time of study completion/discharge

·        Serum creatinine: At admission/ at Diagnosis of AKI/ Worst value during the course/ at the time of study completion/discharge

·        SOFA score

·        Type of patient/ ICU: Surgical/ Medical/ Others

·        Primary diagnosis

·        Comorbidities

o   Coronary artery disease

o   CHF

o   Chronic lung disease

o   Malignancy (Specify…)

o   Hypertension

o   DM

o   Metabolic syndrome

o   Chronic liver disease

·        Surgery/ intervention (if any)

·        Most probable cause of AKI (you may select more than one)

o   Nephrotoxic drugs

o   Haemodynamic instability

o   Volume loss

o   Low cardiac output

o   Post CPR survivor

o   Sepsis

·        Possible type of AKI

o   Pre renal

o   Renal

o   Post renal

o   Unknown

·        Other organ dysfunction during current admission

o   Hepatic

o   Cardiac

o   Neurological

o   Respiratory

·        Other organ support

o   Respiratory (O2/ HFNO/NIV/ Mechanical ventilation)

o   VIS (Vasoactive Inotropic Score)

o   Other Cardiac Support (IABP/ ECMO/ TPI etc)

·        Management of AKI

·        No intervention

·        Medical management (Diuretics type & method)

·        Renal replacement therapy (Type/ duration/ indication/ no of cycles)

·        Outcome

A.

·        Still hospitalized

·        Discharged

·        DAMA

·        Death

B.

o   Complete recovery

o   Partial with No RRT

o   Partial with RRT requirement

o   Non recovery with RRT dependent

 

Analysis: SPSS latest version with appropriate test will be used for analysis and P<0.5 will be considered significant.

 

 
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