| CTRI Number |
CTRI/2022/10/046820 [Registered on: 27/10/2022] Trial Registered Prospectively |
| Last Modified On: |
26/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective observational study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
ROLE OF VEXUS SCORE IN PREDICTING RISK OF ACUTE KIDNEY DAMAGE IN CRITICALLY ILL NON CARDIAC PATIENTS |
|
Scientific Title of Study
|
ROLE OF VEXUS SCORE IN PREDICTING RISK OF ACUTE KIDNEY INJURY CRITICALLY ILL NON CARDIAC PATIENTS: A PROSPECTIVE 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 |
WASEEM AHMAD KHAN |
| Designation |
SENIOR RESIDENT |
| Affiliation |
PGIMER |
| Address |
Department of anaesthesia and intensive care
Level 4
Nehru hospital
PGIMER
Department of anaesthesia and intensive care
Level 4
Nehru hospital
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7652098617 |
| Fax |
|
| Email |
dr.waseemahmadkhan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VIKAS SAINI |
| Designation |
PROFESSOR |
| Affiliation |
PGIMER |
| Address |
DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE CARE,
PGIMER
DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE CARE,
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087008119 |
| Fax |
|
| Email |
drvsaini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VIKAS SAINI |
| Designation |
PROFESSOR |
| Affiliation |
PGIMER |
| Address |
DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE CARE,
PGIMER
DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE CARE,
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087008119 |
| Fax |
|
| Email |
drvsaini@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NONE |
| Address |
NONE |
| Type of Sponsor |
Other [NONE] |
|
|
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 Vikas Saini |
PGIMER |
Department of anaesthesia and intensive care
Level 4
Nehru hospital
Chandigarh
CHANDIGARH |
7652098617
dr.waseemahmadkhan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I998||Other disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All critically ill non-cardiac patients aged 18 years and above admitted to Main ICU of PGIMER Chandigarh, India |
|
| ExclusionCriteria |
| Details |
1. Chronic kidney disease in failure (estimated glomerular filtration rate < 15 ml/min/1.73 m2)
2. Post renal transplantation
3. Pre-existing AKI on admission
4. Nephrotic syndrome
5. Chronic liver disease with cirrhosis/portal hypertension
6. Pancreatitis
7. Congestive heart failure
8. Patients with IVC thrombus
9. Inadequate window
10. Not willing for an ultrasound examination
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the correlation between serial VExUS score and occurrence of acute kidney injury [defined using acute kidney injury network (AKIN) criteria] in critically ill non cardiac patients. |
Till day 7 of ICU stay or until development of new onset AKI (whichever is earlier) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess correlation between VExUS score and cumulative fluid balance
2. To assess correlation between VExUS score and PaO2 / FiO2 (P/F) ratio
3. ICU length of stay
4. 30 day mortality
|
Till day 7 of ICU stay or until development of new onset AKI (whichever is earlier) |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
30/10/2022 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Role of VeXUS score in predicting the risk of acute kidney injury in critically ill non-cardiac patients |