Inferior Vena Cava Collapsibility and Distensibility Assessment in Critical Care.

Jinnah Postgraduate Medical Centre

Status: Completed

Conditions: Acute Gastroenteritis; Diabetic Ketoacidosis; Acute Renal Failure; Sepsis

Treatments: Diagnostic Test: Inferior Vena Cava Collapsibility/distensibility Index (IVC CI/DI) assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT06516692

NO.F.2-81/2023-GENL/64/JPMC

Details and patient eligibility

About

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.

Full 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

Enrollment: 180 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients admitted in critical care with systolic Blood Pressure < 90 mmHg with any of the diagnosis as per operational definition:
• Sepsis
• Diabetic ketoacidosis
• Acute kidney injury
• Acute gastroenteritis

Exclusion criteria

• Known case of right heart disease
• Known case of congestive cardiac failure
• Presence of marked ascites
• IVC could not be identified or diameter could not be measured
• Pregnant females
• Body Mass Index (BMI) >30 Kg/meter2

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Clinical Parameters guided assessment arm

No Intervention group

Description:

Participants recruited to this arm will be assessed for their hydration status and further fluid management as per usual care of assessment through * Capillary refill time * Presence/absence of pulmonary rales. * Jugular venous pressure assessment by clinical methods * Presence / absence of pedal edema

Inferior Vena Cava Collapsibility and Distensibility guided assessment arm

Experimental group

Description:

Participants recruited in this arm will be assessed through measurement of inferior vena cava diameter via subcostal window within 3 cm of its opening to right atrium through point of care ultrasound using a curvilinear or phased array probe. For spontaneously breathing patients Inferior Vena Cava Collapsibility Index (IVC CI) will be calculated as: \[(IVC diameter max-IVC diameter min)/IVC diameter max\]×100% * IVC CI \> 50% = overt hypovolemia * IVC CI \< 20% = no overt hypovolemia * IVC CI of 20% to 50% will be goal For mechanically ventilated patients Inferior Vena Cava Distensibility Index (IVC DI) will be calculated as: \[(IVC diameter max-IVC diameter min)/IVC diameter min\]×100% IVC distensibility\>18% = hypovolemia IVC distensibility\<18% = no hypovolemia

Treatment:

Diagnostic Test: Inferior Vena Cava Collapsibility/distensibility Index (IVC CI/DI) assessment