| CTRI Number |
CTRI/2022/09/045806 [Registered on: 23/09/2022] Trial Registered Prospectively |
| Last Modified On: |
22/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A study to investigate a blood test (Arterial lactate) to predict complications (DCI/Vasospasm) and poor prognosis in patient with aneurysmal SAH. |
|
Scientific Title of Study
|
A Prospective observational study to evaluate serial Arterial lactate as a marker and predictor of delayed cerebral ischemia and poor outcome in patients with aneurysmal SAH |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ARVIN AHUJA |
| Designation |
DM NEUROANAESTHESIA RESIDENT |
| Affiliation |
SREE CHITRA TIRUNAL INSTITUTE FOR MEDICAL SCIENCES AND TECHNOLOGY |
| Address |
Sree Chitra Institute for Medical Sciences and Technology MEDICAL COLLEGE TRIVANDRUM, Jai Nagar W Rd, Chalakkuzhi, Thiruvananthapuram, Kerala 695011
Sree Chitra Institute for Medical Sciences and Technology MEDICAL COLLEGE TRIVANDRUM, Jai Nagar W Rd, Chalakkuzhi, Thiruvananthapuram, Kerala 695011
Thiruvananthapuram
KERALA
695011
India |
| Phone |
7020693549 |
| Fax |
|
| Email |
drarvinahuja@sctimst.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Prasad Hrishi |
| Designation |
Additional Professor, Division of Neuroanaesthesia and Neurocritical Care |
| Affiliation |
SREE CHITRA TIRUNAL INSTITUTE FOR MEDICAL SCIENCES AND TECHNOLOGY |
| Address |
Sree Chitra Institute for Medical Sciences and Technology MEDICAL COLLEGE TRIVANDRUM, Jai Nagar W Rd, Chalakkuzhi, Thiruvananthapuram, Kerala 695011
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9495239765 |
| Fax |
|
| Email |
drajay@sctimst.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Prasad Hrishi |
| Designation |
Additional Professor, Division of Neuroanaesthesia and Neurocritical Care |
| Affiliation |
SREE CHITRA TIRUNAL INSTITUTE FOR MEDICAL SCIENCES AND TECHNOLOGY |
| Address |
Sree Chitra Institute for Medical Sciences and Technology MEDICAL COLLEGE TRIVANDRUM, Jai Nagar W Rd, Chalakkuzhi, Thiruvananthapuram, Kerala 695011
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9495239765 |
| Fax |
|
| Email |
drajay@sctimst.ac.in |
|
|
Source of Monetary or Material Support
|
| SREE CHITRA TIRUNAL INSTITUTE OF MEDICAL SCIENCES AND NTECHNOLOGY, TRIVANDRUM, KERALA 695011 |
|
|
Primary Sponsor
|
| Name |
SCTIMST |
| Address |
Sree Chitra Institute of Medical Science and Technology MEDICAL COLLEGE TRIVANDRUM, Jai Nagar W Rd, Chalakkuzhi, Thiruvananthapuram, Kerala 695011 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 ARVIN AHUJA |
SREE CHITRA TIRUNAL INSTITUTE FOR MEDICAL SCIENCES AND TECHNOLOGY |
Sree Chitra Institute for Medical Sciences and Technology MEDICAL COLLEGE TRIVANDRUM, Jai Nagar W Rd, Chalakkuzhi, Thiruvananthapuram, Kerala 695011
Thiruvananthapuram
KERALA |
7020693549
drarvinahuja@sctimst.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Regn No. ECR/189/Inst/KL/2013/RR-21) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I609||Nontraumatic subarachnoid hemorrhage, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
-Consenting Adult patients (Caregivers in-case of incapacitated patients) with aSAH admitted at SCTIMST
-Age group 18 years and above (with both sexes included)
-Anterior Circulation Bled Aneurysms |
|
| ExclusionCriteria |
| Details |
-Patients/caregivers not consenting for participation in the study.
-Patients with history of Heart Failure/Renal failure/Liver Failure/Shock/Alcoholism/Malignancy -Patients with known congenital errors of Metabolism -Patients on antiretrovirals (NRTI)/Metformin/ Salicylates/beta-adrenergic agonists
-Pregnant/Nursing mothers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study serial arterial blood lactate levels in patients presenting with aSAH and check for any correlation between its levels and time to onset of DCI and incidence of DCI. |
Time to occurrence of Vasospasm or DCI |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To check for any correlation between arterial lactate levels and other outcome parameters. |
Time to discharge from Hospital |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
26/09/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
26/09/2022 |
| 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
|
Will provide once published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a hospital based prospective observational study in which patients with aneurysmal sub arachnoid haemorrhage will be enrolled and their serial arterial lactate level trends will be analysed to check for any correlation between lactate levels and incidence of delayed cerebral ischemia/ vasospasm and poor outcomes. |