Comparison of Fluid Resuscitation in Pediatric Burn Patients Using Crystalloids and With Albumin on Day Two.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Resuscitation Volume
研究概览
简要总结
The goal of this comparative, interventional randomized controlled trial is to use albumin during resuscitation in pediatric burn patients on day 2, as it can reduce extravasation of fluids and decrease the overall fluid requirements, along with mortality and maintain circulation.
Participants will be divided into 2 groups. Albumin will be administered additionally in group A, while only crystalloids will be used for resuscitation in group B.
详细描述
The randomized controlled trial will be done at Department of Pediatric Surgery, Mayo Hospital Lahore from January 2022 to December 2022. Ninety patients (forty-five patients in each group) will be enrolled using a non probability convenient sampling technique. Patients will be randomly divided into 2 groups. Albumin solution will be administered in group A and in group B only routine crystalloids will be given. Basic demographic information will be noted. Effect modifiers (hemoglobin, Albumin level, weight and height) will be noted.
Group A: After first 24 hours, maintenance fluid, N/2+5%Dextrose solution will be started according to weight(100ml/kg/day for first 10kg, 50ml/kg/day for next 10kg and 20ml/kg/day for the remainder) and will be increased or decreased by 1/3 to maintain the urinary output to 1-1.5ml/kg/hour. 12, 75 5% Albumin solution will be administered @0.5ml/kg/%burn over initial 8 hours of day 2 and It's amount will be subtracted from the 24 hours fluid calculated earlier.
Group B: After first 24 hours, maintenance fluid, N/2+5%Dextrose solution will be started according to weight (100ml/kg/day for first 10kg, 50ml/kg/day for next 10kg and 20ml/kg/day for the remainder) and will be increased or decreased by 1/3 to maintain the urinary output to 1-1.5ml/kg/hour.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •25-40%, less than 12 hours old, scald or flame burn patients
- •Full thickness
排除标准
- •Burns with inhalational injury.
- •Patients hypersensitive to Albumin.
- •Deranged renal or hepatic profile.
- •Patients with known Cardiac or debilitating Congenital anomalies.
- •Patients with known metabolic disease.
- •Burns associated with trauma including fractures, head injuries, intra-abdominal bleed etc.
- •Albumin level lower than 1.8g/dl at time of admission.
研究组 & 干预措施
Albumin Group A
5% Albumin solution will be administered on day 2 @0.5ml/kg/%burn over 8 hours,in addition to required crystalloids.
干预措施: 5% Albumin (human) Solution (Biological)
Albumin Group A
5% Albumin solution will be administered on day 2 @0.5ml/kg/%burn over 8 hours,in addition to required crystalloids.
干预措施: Paeds solution (Drug)
Crystalloid Group B
Routine Crystalloids will be administered according to weight of the patient.
干预措施: Paeds solution (Drug)
结局指标
主要结局
Resuscitation Volume
时间窗: 24-48 hours
Total volume of fluid required to maintain a urine output of 1-1.5ml/hour on the day 2 of admission.
Urine Output
时间窗: 24-48 hours
Amount of urine passed on day 2 of admission. Should be 1-2.5ml/kh/hr
Serum Albumin levels
时间窗: 24-48 hours
Albumin level in patient after day 2 of admission
次要结局
- Mortality(First 5 days of admission)
- Requirement of inotropic support(24-48 hours)