| CTRI Number |
CTRI/2024/07/071659 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Outcomes of Early versus Late Initiation of Continuous Renal Replacement Therapy in critically ill patients |
|
Scientific Title of Study
|
A study to evaluate outcomes after Early versus Late initiation of Continuous Renal Replacement Therapy in critically ill adult patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. S.S.Nath |
| Designation |
Professor |
| Affiliation |
Dr. Ram Manohar Lohia Institute of Medical sciences, Lucknow |
| Address |
Department of Anaesthesiology and CCM, DR. Ram Manohar Lohia Institute of Medical sciences, Vibhuti Khand, Lucknow
Vibhuti Khand, Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8176007253 |
| Fax |
|
| Email |
soumynath2185@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. S.S. Nath |
| Designation |
PROFESSOR |
| Affiliation |
DR. RAM MANOHAR LOHIA INSTITUTE OF MEDICAL SCIENCES, LUCKNOW |
| Address |
Department of Anaesthesiology and CCM, DR. RAM MANOHAR LOHIA INSTITUTE OF MEDICAL SCIENCES, VIBHUTI KHAND, LUCKNOW
Vibhuti Khand, Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8176007253 |
| Fax |
|
| Email |
soumynath2185@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. S.S.Nath |
| Designation |
Professor |
| Affiliation |
Dr. Ram Manohar Lohia Institute of Medical sciences, Lucknow |
| Address |
Department of Anaesthesiology and CCM, Dr. Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Lucknow
Vibhuti Khand, Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8176007253 |
| Fax |
|
| Email |
soumynath2185@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and CCM, Dr. RMLIMS, Vibhuti khand, Lucknow, Uttar pradesh, India, 226010 |
|
|
Primary Sponsor
|
| Name |
Dr Ram Manohar Lohia Institute of Medical Sciences |
| Address |
Department of Anaesthesiology and CCM, Dr. Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Uttar Pradesh, India, 226010 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR HINA ASHRAF |
Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow |
Department of Anaesrthesiology and CCM, Room, 512, Dr. SC. Rai, DR. Ram Manohar Lohia Institue of Medical sciences, Vibhuti khand, Lucknow
Lucknow
UTTAR PRADESH |
8576090207
hinaashraf1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Ram Manohar Lohia Institute Medical Sciences, Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N179||Acute kidney failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Observational study |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Consenting adults ages between 20 to 65 years
2. Patients compatible with the diagnosis of AKI at stage 2 of KDIGO classification
3. More than two fold increase of serum creatinine level compared with the baseline value and urine output less than 05 ml/kg/hour |
|
| ExclusionCriteria |
| Details |
1. Declined consent from guardian
2. Pre-existing severe chronic renal failure (Estimated glomerular filtration rate less than 30 ml/min)
3. Previous RRT |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| 28 day mortality among critically ill patients with early versus late initiation of continuous renal replacement therapy |
1st August to 31st May (10 months) recruitment of patients
1st June to 30th June (4 weeks) Data Analysis
1st July to 15 July (2 weeks) writing of manuscript
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare renal recovery rate among critically ill patients with early versus late initiation of Continuous renal Replacement therapy |
1st August to 31st May (10 months) recruitment of patients
1st June to 30th June (4 weeks) Data Analysis
1st July to 15 July (2 weeks) writing of manuscript |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
15/08/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Early CRRT group Patients receiving CRRT at KDIGO Stage II AKI (Patients developing Acute Kidney Injury During the ICU stay) will be designated as early CRRT group. A maximum of 8 hours is allowed between clinical decision regarding initiating CRRT and the actual initiation of CRRT. Delayed CRRT group Patients not receiving CRRT at AKI Stage II or patients getting admitted in ICU with diagnosed Chronic Kidney Disease included in the delayed CRRT group AIM To evaluate 28- day mortality and renal recovery rate after Early versus Late initiation of Continuous Renal replacement therapy in Critically ill Adult patients Primary Objective · To compare 28-day mortality among critically ill patients with early versus late initiation of Continuous Renal Replacement Therapy Secondary Objective · To compare renal recovery rate among critically ill patients with early versus late initiation of Continuous Renal Replacement Therapy · To study the length of stay in Intensive Care Unit and hospital Total sample Size is 32 INCLUSION CRITERIA 1. Consenting adults aged between 20 to 65 years 2. Patients compatible with the diagnosis of AKI at stage 2 of KDIGO classification. 3. More than two fold increase of Serum creatinine level compared with the baseline value and/or urine output less than 0.5ml/kg/hour for 12 hours Exclusion criteria 1. Declined consent from guardian 2. Pre-existing severe chronic renal failure (estimated Glomerular Filtration rate less than 30 ml/min) 3. Previous RRT
|