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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
180
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.
Jinnah Post graduate Medical Centre
Karachi, Sindh, Pakistan
Within 24-hours, 7-day and 28 day mortalities
Death of participant will be considered mortality.
Time frame: Mortalities will be assessed and recorded within 24hour, then day 7 up to 28th day.
Cumulative fluid balance
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.
Time frame: At 6 hours of enrolment of participant
Change in Sequential Organ Failure Assessment score(Δ SOFA)
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.
Time frame: At 24 hours of enrolment
Days in Intensive Care Unit (ICU)
Total ICU stay in days will be noted
Time frame: ICU days up to 28 day
Days on mechanical ventilation
This outcome will be measured for the participants who will be mechanically ventilated.
Time frame: Days in which participant will be on mechanical ventilation up to 28 days
Change in lactic acid levels in septic patient
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
Time frame: At 6 hours of enrolment of participant
Change in Blood Sugar random (BSR) levels in patients with diabetic ketoacidosis
This outcome will be measured in mg/dL in patients with diagnosis of diabetic ketoacidosis in the trial
Time frame: At 6 hours of enrolment of participant
Change in Power of hydrogen (PH) in patients with sepsis and diabetic ketoacidosis
This outcome will be calculated as difference of values from time of enrolment to 6 hours.
Time frame: At 6 hours of enrolment of participant
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