Standard therapy versus PLasmalyte In children with Dengue Shock Syndrome (SPLID TRIAL): an open labelled randomised control trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- ≥ 5mmol/L increase in serum chloride level within 48 hours (h) post-randomization.
研究概览
简要总结
Dengue Shock Syndrome (DSS) is the most serious manifestation of dengue fever. Standard therapy in DSS consists of fluid
therapy with isotonic crystalloids like Normal Saline (NS) or Ringer lactate (RL). Recently, the focus has shifted from unbalanced to
balanced fluids. Balanced crystalloids are sodium-based solutions with chloride content less than 154 mmol/L with added buffers
for better approximation of plasma composition. Balanced solutions like RL or Plasmalyte (PL) are isotonic and have chloride
concentration more like that of plasma, unlike NS. The optimal fluid therapy in DSS is mainly consensus based and currently there
is little evidence in children over which is the most optimal fluid for resuscitation in DSS. As the burden of dengue fever and
consequently DSS is on rise, it is of paramount importance to study the benefits and adverse effects of these fluids. Hence, we
planned this trial to examine if Plasmalyte (PL) causes less chloride rise and better preservation of renal functions compared to
standard therapy (i.e NS or RL) in children with DSS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 2.00 Month(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Children suffering from dengue shock syndrome (DSS) will be enrolled.
- •DSS will be defined as DHF as well as hypotension, tachycardia, narrow pulse pressure (less than/equal to 20 mmHg) and signs of poor perfusion (e.g cold extremities, delayed capillary filling time, feeble pulses).
- •Dengue Haemorrhagic Fever (DHF) will be defined as a child fulfilling clinical criteria of dengue fever with bleeding tendencies viz., petechiae, ecchymoses or purpura, positive tourniquet test and/or skin, mucosal or gastrointestinal bleed with thrombocytopenia (<100000 cells per mm3) with increased vascular permeability (viz.
- •> 20% increase in haematocrit, >20% decrease in haematocrit after fluid therapy, pleural effusion, ascites, hypoproteinemia).
排除标准
- •Children already received fluids from outside before enrolment in last 6 h 2) Children with cardiogenic shock 3) Known patient with chronic kidney disease as per KDIGO.
- •Severe malnutrition defined as per WHO.
- •Children whose parents deny consent.
结局指标
主要结局
≥ 5mmol/L increase in serum chloride level within 48 hours (h) post-randomization.
时间窗: Baseline, 48 hours
次要结局
- hospital stay duration, need for colloid bolus, incidence of hyponatremia (serum sodium less than 135 mmol/L in the first 48 h of fluid management), new-onset AKI, standard base excess, serum lactate levels, renal replacement therapy, organ dysfunction (25)and serum magnesium levels.(first 48 hours, during hospital stay)
研究者
Vidushi Mahajan
Government Medical College and Hospital Chandigarh