NCT06516692

Inferior Vena Cava Collapsibility and Distensibility Assessment in Critical Care.

(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
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Jinnah Postgraduate Medical Centre · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Sepsis
• Acute Renal Failure
• Acute Gastroenteritis
• Diabetic Ketoacidosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Inferior Vena Cava Collapsibility/distensibility Index (IVC CI/DI) assessment	Assessment of hydration status in critically ill patient recruited to this arm will be intervened through an ultrasound guided calculation of collapsibility and distensibility index of Inferior Vena Cava. This method of intervention will be continued and repeated as needed throughout the stay of the participant in intensive care unit.

Timeline

• Start date: 2024-08-01
• Primary completion: 2024-11-30
• Completion: 2024-11-30
• First posted: 2024-07-24
• Last updated: 2024-12-05

Locations

1 site across 1 country: Pakistan

Regulatory

• FDA-regulated device study