| CTRI Number |
CTRI/2023/10/058755 [Registered on: 17/10/2023] Trial Registered Prospectively |
| Last Modified On: |
06/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
clinical profile of acute kidney injury |
|
Scientific Title of Study
|
clinical and etiological profile of acute kidney injury in patients admitted to intensive care units |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gnyanavi Sai Chittela |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College and Hospital |
| Address |
Department of General Medicine , Kasturba Medical College , Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9492294333 |
| Fax |
|
| Email |
gnyanavi29@gmai.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr. Vasudeva Acharya |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College manipal |
| Address |
Department of General Medicine second floor OPD block, Kasturba Medical College, Manipal Karnataka
576104 Kasturba Medical College Tiger Circle Road, Madhav Nagar,
Manipal, Karnataka 576104
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
8197597006 |
| Fax |
|
| Email |
acharya.vasudev@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
DR Nandakrishna |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College manipal |
| Address |
Department of General Medicine second floor OPD block, Kasturba Medical College, Manipal Karnataka
576104 Kasturba Medical College Tiger Circle Road, Madhav Nagar,
Manipal, Karnataka 576104
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9914201838 |
| Fax |
|
| Email |
nanda.bhat@manipal.edu |
|
|
Source of Monetary or Material Support
|
| kasturba hospital,manipal |
|
|
Primary Sponsor
|
| Name |
Dr Gnyanavi Sai Chittela |
| Address |
Department of General Medicine second floor OPD block, Kasturba Medical College, Manipal Karnataka
576104 Kasturba Medical College Tiger Circle Road, Madhav Nagar,
Manipal, Karnataka 576104
Udupi |
| Type of Sponsor |
Other [self] |
|
|
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 Gnyanavi Sai Chittela |
Kasturba Hospital, Manipal |
Department of General Medicine second floor OPD block, Kasturba Medical College, Manipal Karnataka
576104 Kasturba Medical College Tiger Circle Road, Madhav Nagar,
Manipal, Karnataka 576104
Udupi
Udupi
KARNATAKA |
9492294333
gnyanavi29@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics commitee-2 |
Approved |
| Kasturba Medical College and Kasturba Hospital I Institutional Ethics Committee 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N17||Acute kidney failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients admitted to icu with acute kindey injury |
|
| ExclusionCriteria |
| Details |
1.18years of age
2.Chronic kidney disease with end stage renal disease
3.Pregnancy
4.Chronic liver disease patients
5.Those on metformin
5.Malignancy |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| clinical profile of patients with acute kidney injury in ICU patients |
at time of discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-to accesses lactate albumin ratio in predicting mortality of patient
-dialysis dependence analyzed |
at time of discharge |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
26/10/2023 |
| 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="1"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Need for study acute kidney injury incidence corresponds to almost 50%of all cause ICU admissions. AKI can be transient , persistent or acute kidney disease . there are still research gaps in the various causes and outcome of various causes of acute kidney injury , especially in developing countries , as the causes are different in both developing and developed countries . AKI reversal is observed in 72.9%of all AKI patients .
the risk of in hospital mortality , and ICU mortality increases with increased in lactate albumin ratio according to a study. Patients with higher lactate albumin ratio showed significant shorter survival time .
Description
patients are selected from ICU after they meet selection criteria for study . after taking written consent from the patient , data is collected including demographic profile, clinical symptoms , comorbidities , biochemical and etiological profile of the patient are collected as part of the study . laboratory data is collected . initial serum lactate and serum albumin values were taken from within 48 hrs of admission duration of stay was noted. the treatment information including hemodialysis .
data is analysed , lactate albumin ratio is calculated and analysed . patients are divided into 4 quartiles . mortality rates in relation to each quartile are analysed . patients are followed up till discharge and status at discharge noted. dialysis dependence is analysed . data is analysed using appropriate stastical methods used for analysis . |