| CTRI Number |
CTRI/2021/04/032778 [Registered on: 13/04/2021] Trial Registered Prospectively |
| Last Modified On: |
04/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
To detect serum cystatin C levels in postoperative exploratory laparotomy patients who are admitted in intensive care unit to find out acute kidney injury |
Scientific Title of Study
Modification(s)
|
Evaluation of serum cystatin C for early diagnosis of acute kidney injury in post exploratory laparotomy patients in intensive care unit |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shambhavi Sharma |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Government medical college and hospital, Chandigarh |
| Address |
Government Medical College and Hospital Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9606322036 |
| Fax |
|
| Email |
shambhavijan28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manpreet Singh |
| Designation |
Professor |
| Affiliation |
Government medical college and hospital, Chandigarh |
| Address |
Government Medical College and Hospital Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121503 |
| Fax |
|
| Email |
manpreetdawar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shambhavi Sharma |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Government medical college and hospital, Chandigarh |
| Address |
Government Medical College and Hospital Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9606322036 |
| Fax |
|
| Email |
shambhavijan28@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia Government Medical College
Sector 32 Chandigarh |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia GMCH Chandigarh |
| Address |
Government Medical College and Hospital
Sector 32 Chandigarh |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shambhavi Sharma |
Department of Anaesthesia |
Government Medical College and Hospital
sector 32
Chandigarh
Chandigarh
CHANDIGARH |
9606322036
shambhavijan28@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics core committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N179||Acute kidney failure, unspecified, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients with age 18 years – 60 years admitted to ICU after post-operative exploratory laparotomy surgery |
|
| ExclusionCriteria |
| Details |
Refusal to consent from patient’s relative
Patients recovering from AKI or developing AKI
Patients who required renal replacement therapy
All patients transferred from another ICU
Patients with end stage kidney disease
Serum Creatinine beyond range
Serum Cystatin C level beyond range
Covid 19 and covid 19 suspect patients
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of serum cystatin C for the early diagnosis of AKI in the postoperative exploratory laparotomy patients who will be admitted in the intensive care unit |
Within 24 hours post admission in ICU(Baseline)
After 48 hours post admission in ICU
After 72 Hours post admission in ICU
Day 7 post admission in ICU |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation of serum cystatin C and serum creatinine in early diagnosis of AKI in the postoperative exploratory laparotomy patients who will be admitted in the intensive care unit. |
Within 24 hours post admission in ICU(Baseline)
After 48 hours post admission in ICU
After 72 Hours post admission in ICU
Day 7 post admission in ICU |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
25/04/2021 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Acute kidney injury is commonly seen in the perioperative period and in the ICU and is associated with a prolonged hospital stay and high morbidity and mortality. Upto 30% of all patients admitted in ICU suffer from acute kidney injury. About 50-90% mortality rate is seen in ICU patients who at the end require renal transplantation. Hence, the need for early diagnosis of acute kidney injury is required for the early intervention with prompt implementation of therapeutic measures to save lives. Criteria for early diagnosis of acute kidney injury are available including : RIFLE criteria (Risk, Injury ,Failure, Loss and End stage kidney), AKIN (Acute kidney injury network), KDIGO( Kidney Disease Improving Global Outcomes). All these are based on serial measurement of serum creatinine and urine output. Serum creatinine is the most common and dominant marker of Glomerular filtration rate used to make diagnosis and to categorize acute kidney injury in the ICU setting. Serum cystatin C is also an alternative endogenous marker of glomerular filtration rate. It is produced by all nucleated cells at a constant rate, it’s serum level is only determined by glomerular filtration rate. An ideal marker of acute kidney injury is the one which allows for the early detection with high diagnostic sensitivity and specificity. The present study will be conducted in the Department of Anaesthesia and Intensive care, Government Medical College and Hospital, Chandigarh. 70 postoperative exploratory laparotomy patients admitted to ICU, will be enrolled in the study based on inclusion / exclusion criteria. 5 ml blood sample will be taken from the patients: on the Day 0 i.e. in first 24 hours of admission to ICU(baseline), 48hours, 72 hours and on day 7 of admission to ICU. Acute kidney injury will be defined according to KDIGO criteria. The immunoturbidimetric method on automated random assess chemistry analyser will be used for the determination of serum cystatin C level. Serum samples for serum cystatin C will be collected and frozen at -80 degree centigrade. From this study we hypothesize that for the early diagnosis of acute kidney injury in postoperative laparotomy patient who are admitted in ICU, serum cystatin is a better marker than serum creatinine.
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