| CTRI Number |
CTRI/2024/07/070638 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
06/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
How Stress-Related Blood Sugar Levels and Cortisol Help Predict Complications After Brain Aneurysm Rupture
|
|
Scientific Title of Study
|
The Utility of stress Hyperglycemia Ration (SHR) and Serum Cortisol in Prediction of delayed Ischemic Neurologic Deficit (DIND) in patients with aneurysmal subarachnoid hemorrhage: A Prospective Cohort Study
|
| 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 Shweta Suresh Naik |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Faculty Building Third Floor Department of Neuroanaesthesia and
Neurocritical care National Institute of Mental Health and
Neurosciences Hosur Main Road
Bangalore
KARNATAKA
560029
India |
| Phone |
9986308719 |
| Fax |
|
| Email |
neurodocms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta Suresh Naik |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Faculty Building Third Floor Department of Neuroanaesthesia and
Neurocritical care National Institute of Mental Health and
Neurosciences Hosur Main Road
Bangalore
KARNATAKA
560029
India |
| Phone |
9986308719 |
| Fax |
|
| Email |
neurodocms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Suresh Naik |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Faculty Building Third Floor Department of Neuroanaesthesia and
Neurocritical care National Institute of Mental Health and
Neurosciences Hosur Main Road
Bangalore
KARNATAKA
560029
India |
| Phone |
9986308719 |
| Fax |
|
| Email |
neurodocms@gmail.com |
|
|
Source of Monetary or Material Support
|
| Neurocritical care society of India
#115, First Floor, Office Block, Jai Prakash Narayan Apex Trauma Centre (JPNATC), All India Institute of Medical Sciences (AIIMS), New Delhi - 110029. |
|
|
Primary Sponsor
|
| Name |
Dr Shweta Suresh Naik |
| Address |
Faculty Building Third Floor Department of Neuroanaesthesia and
Neurocritical Care National Institute of Mental Health and
Neurosciences Hosur Main road Bengaluru Karnataka-560028 |
| 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 Shweta Suresh Naik |
National Institute of Mental Health and Neurosciences |
Department of
Neuroanaesthesia and
Neurocritical Care
National Institute of
Mental Health and
Neurosciences Hosur
Main road Bengaluru
Karnataka-560028
Bangalore
KARNATAKA |
9986308719
neurodocms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I60||Nontraumatic subarachnoid hemorrhage, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Confirmed diagnosis of aSAH based on CT |
|
| ExclusionCriteria |
| Details |
Known adrenal disorders.
- Pregnancy.
- Established vasospasm in the initial CT imaging
- Patient on steroids |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the association between stress hyperglycaemia ratio (SHR) and occurrence of delayed ischemic neurologic deficit (DIND) in patients with aSAH. |
Baseline,discharge ,2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the relationship between SHR & serum cortisol levels in patients with aSAH |
baseline |
|
|
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)
|
01/08/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Aneurysmal subarachnoid hemorrhage (aSAH), characterized by bleeding in the subarachnoid space due to aneurysm rupture, and remains a critical neurosurgical challenge. Its devastating impact stems not only from the initial hemorrhage but also from delayed complications like vasospasm leading to worsening outcomes. Early identification of DIND is crucial for guiding preventative and therapeutic interventions. The quest for non-invasive predictors of DIND has led to exploring readily available biomarkers, like stress hyperglycemia ratio (SHR) and serum cortisol. The intricate interplay between stress, hyperglycemia, and vasospasm in aSAH is well-documented in scientific literature. This study aims to assess the utility of SHR and serum cortisol levels in predicting delayed ischemic neurologic deficit (DIND) in patients with aSAH |