Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2026-01-03 @ 11:08 PM
Study NCT ID:
NCT06516692
Status:
COMPLETED
Last Update Posted:
2024-12-05
First Post:
2024-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inferior Vena Cava Collapsibility and Distensibility Assessment in Critical Care.
Sponsor:
Jinnah Postgraduate Medical Centre
Organization:
Study Overview
Official Title:
(IVCIN TRIAL) Outcomes of Patient Admitted to Critical Care Unit with Vs Without Inferior Vena Cava Collapsibility and Distensibility Assessment. a Randomized Clinical Trial in Pakistan.
Status:
COMPLETED
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will help in determining the impact of assessment of Inferior Vena Cava Collapsibility and Distensibility Index (IVC CI and DI) through Point Of Care Ultra Sound (POCUS), for the fluid management of critically ill patients. This would help in better management of such patients in resource limited countries, where costly equipment for cardiac output monitoring and fluid management are frequently not available.
Moreover this study will help in development of future guidelines for fluid resuscitation in critically ill patients.
Moreover this study will help in development of future guidelines for fluid resuscitation in critically ill patients.
Detailed Description:
The current study is a randomized clinical trial with the aim to explore comparative outcome between IVC CI and DI versus clinical parameters guided fluid management groups in patients of sepsis, Acute renal failure, Acute gastroenteritis and Diabetic ketoacidosis in terms of,
1. Within 24 hours 7 day and 28 day mortality
2. Change in Sequential Organ failure Assessment (ΔSOFA) score from baseline to 24 hours after fluid management.
3. Cumulative fluid balance at 6 hours of fluid management
4. Days on mechanical ventilation
5. Days in Intensive Care Unit (ICU)
6. Change in lactic acid levels in sepsis sub group
7. Change in Blood sugar Random (BSR) in Diabetic ketoacidosis (DKA) sub group
8. Change in Power of Hydrogen (PH) in septic and diabetic ketoacidosis sub group of participant
1. Within 24 hours 7 day and 28 day mortality
2. Change in Sequential Organ failure Assessment (ΔSOFA) score from baseline to 24 hours after fluid management.
3. Cumulative fluid balance at 6 hours of fluid management
4. Days on mechanical ventilation
5. Days in Intensive Care Unit (ICU)
6. Change in lactic acid levels in sepsis sub group
7. Change in Blood sugar Random (BSR) in Diabetic ketoacidosis (DKA) sub group
8. Change in Power of Hydrogen (PH) in septic and diabetic ketoacidosis sub group of participant
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: