Inferior Vena Cava Collapsibility and Distensibility Assessment in Critical Care.
- Conditions
- Acute GastroenteritisAcute Renal FailureDiabetic KetoacidosisSepsis
- Interventions
- Diagnostic Test: Inferior Vena Cava Collapsibility/distensibility Index (IVC CI/DI) assessment
- Registration Number
- NCT06516692
- Lead Sponsor
- Jinnah Postgraduate Medical Centre
- 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.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Inferior Vena Cava Collapsibility and Distensibility guided assessment arm Inferior Vena Cava Collapsibility/distensibility Index (IVC CI/DI) assessment 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
- Primary Outcome Measures
Name Time Method Change in Sequential Organ Failure Assessment score(Δ SOFA) At 24 hours of enrolment A difference will be noted in initial Sequential Organ Failure Assessment score ( from 0 up to 24) to score at 24 hours .A positive difference in score will be considered as improvement and a negative difference will be considered as worsening in outcomes. Values for cumulative SOFA scores as well as individual organ SOFA scores for hepatic, neurological, cardiovascular, renal, coagulopathy and respiratory will be analyzed.
Cumulative fluid balance At 6 hours of enrolment of participant A difference of total amount of fluids given both intravenously and through oral rout to a total amount of urine output or fluid removed during dialysis, calculated in milliliter (ml) will be taken as cumulative fluid balance.
Within 24-hours, 7-day and 28 day mortalities Mortalities will be assessed and recorded within 24hour, then day 7 up to 28th day. Death of participant will be considered mortality.
- Secondary Outcome Measures
Name Time Method Change in lactic acid levels in septic patient At 6 hours of enrolment of participant This outcome will be measured as difference of values from the time of enrolment to 6 hours in mmol/L in patients with diagnosis of sepsis in the trial
Days in Intensive Care Unit (ICU) ICU days up to 28 day Total ICU stay in days will be noted
Change in Blood Sugar random (BSR) levels in patients with diabetic ketoacidosis At 6 hours of enrolment of participant This outcome will be measured in mg/dL in patients with diagnosis of diabetic ketoacidosis in the trial
Days on mechanical ventilation Days in which participant will be on mechanical ventilation up to 28 days This outcome will be measured for the participants who will be mechanically ventilated.
Change in Power of hydrogen (PH) in patients with sepsis and diabetic ketoacidosis At 6 hours of enrolment of participant This outcome will be calculated as difference of values from time of enrolment to 6 hours.
Trial Locations
- Locations (1)
Jinnah Post graduate Medical Centre
🇵🇰Karachi, Sindh, Pakistan