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(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.
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.
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
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Jinnah Post graduate Medical Centre
Karachi, Sindh, Pakistan
Start Date
August 1, 2024
Primary Completion Date
November 30, 2024
Completion Date
November 30, 2024
Last Updated
December 5, 2024
180
ACTUAL participants
Inferior Vena Cava Collapsibility/distensibility Index (IVC CI/DI) assessment
DIAGNOSTIC_TEST
Lead Sponsor
Jinnah Postgraduate Medical Centre
NCT04850456
NCT04955210
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT05267821