(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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Change in Sequential Organ Failure Assessment score(Δ SOFA)
研究概览
简要总结
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.
详细描述
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,
- Within 24 hours 7 day and 28 day mortality
- Change in Sequential Organ failure Assessment (ΔSOFA) score from baseline to 24 hours after fluid management.
- Cumulative fluid balance at 6 hours of fluid management
- Days on mechanical ventilation
- Days in Intensive Care Unit (ICU)
- Change in lactic acid levels in sepsis sub group
- Change in Blood sugar Random (BSR) in Diabetic ketoacidosis (DKA) sub group
- Change in Power of Hydrogen (PH) in septic and diabetic ketoacidosis sub group of participant
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted in critical care with systolic Blood Pressure < 90 mmHg with any of the diagnosis as per operational definition:
- •Diabetic ketoacidosis
- •Acute kidney injury
- •Acute gastroenteritis
排除标准
- •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
结局指标
主要结局
Change in Sequential Organ Failure Assessment score(Δ SOFA)
时间窗: 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
时间窗: 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
时间窗: Mortalities will be assessed and recorded within 24hour, then day 7 up to 28th day.
Death of participant will be considered mortality.
次要结局
- Change in lactic acid levels in septic patient(At 6 hours of enrolment of participant)
- Days in Intensive Care Unit (ICU)(ICU days up to 28 day)
- Change in Blood Sugar random (BSR) levels in patients with diabetic ketoacidosis(At 6 hours of enrolment of participant)
- Days on mechanical ventilation(Days in which participant will be on mechanical ventilation up to 28 days)
- Change in Power of hydrogen (PH) in patients with sepsis and diabetic ketoacidosis(At 6 hours of enrolment of participant)