Acute Gastroenteritis, Acute Renal Failure, Diabetic Ketoacidosis, Sepsis
Conditions
Keywords
Inferior Vena Cava Collapsibility and Distensibility index, Fluid management, Resuscitation, Clinical parameters, Sepsis, Acute gastroenteritis, Acute Renal failure, Diabetic ketoacidosis, Mortality, Cumulative fluid balance, Lactic acid, Sequential Organ Failure Assessment score, Mechanical Ventilation, Critical Care
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
Interventions
DIAGNOSTIC_TESTInferior 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.
Sponsors
Jinnah Postgraduate Medical Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 in Intensive Care Unit (ICU) | ICU days up to 28 day | Total ICU stay in days will be noted |
| 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. |
| 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 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 |
Countries
Pakistan
Outcome results
None listed