A Randomized Double-blind Controlled Pilot Feasibility and Safety Trial of NGAL-directed Sodium Bicarbonate to Protect Renal Function in Patients With the Systemic Inflammatory Response Syndrome, Oliguria and Elevated Lipocalin Levels
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- The ability to deliver the study protocol safely and rapidly with a trend to improved renal outcomes
研究概览
简要总结
The investigators will determine the feasibility, safety and efficacy of intravenous sodium bicarbonate in reducing progression to overt acute renal failure in patients with the systemic inflammatory response syndrome, and low urine output or early acute renal impairment as defined by serum neutrophil gelatinase-associated lipocalin (NGAL).
详细描述
The investigators hypothesise:
- In patients with SIRS and oliguria the early administration of sodium bicarbonate or sodium chloride (control) triggered by an abnormally high NGAL level is feasible.
- In patients with SIRS and oliguria the early administration of sodium bicarbonate or sodium chloride (control) triggered by an abnormally high NGAL level is safe.
- In patients with SIRS and oliguria the early administration of sodium bicarbonate or sodium chloride (control) triggered by an abnormally high NGAL level leads to signs or trends of efficacy as measured by serum creatinine derived indices.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consent obtained
- •Diagnosis of SIRS. Requires any TWO of:
- •temperature > 38°C or < 36°C OR heart rate > 90 beats/min OR respiratory rate > 20 breaths/min. PaCO2 < 32 mm Hg OR alteration of white blood cell count > 12,000 cells/mm3, < 4,000 cells/mm3, or the presence of > 10% immature neutrophils
- •elevated lipocalin level
- •Arterial line already in place
- •Central venous catheter already in place
- •Age ≥ 18 years
- •Within 24 hours of admission to the ICU
排除标准
- •Unlikely to remain in ICU for >72 hours
- •Moribund patient
- •Pre-existing CKD, transplant or ESRD
- •Receiving (or about to receive) continuous renal replacement therapy for acute renal failure at time of enrolment
- •Diagnosis of acute GN, AIN, vasculitis or post-renal aetiology
- •Known/suspected study allergy to sodium bicarbonate
- •Enrolling physician concern about patient enrolment
研究组 & 干预措施
Sodium bicarbonate
sodium bicarbonate: loading of 0.5 mmol/kg and the continuous infusion o f0.2 mmol/kg/hr
干预措施: Sodium bicarbonate (Drug)
Sodium chloride
sodium chloride: loading of 0.5 mmol/kg and the continuous infusion o f0.2 mmol/kg/hr
干预措施: Sodium chloride (Drug)
结局指标
主要结局
The ability to deliver the study protocol safely and rapidly with a trend to improved renal outcomes
时间窗: 28 days
次要结局
- Attenuation in lipocalin levels(28 days)
- Decrease in the magnitude in serum creatinine rise(28 days)
- Ability to deliver the study protocol without significant biochemical side effects(28 days)
研究者
Rinaldo Bellomo
Director of Intensive Care Research
Austin Health