The SODa-BIC RCT SODium BICarbonate for Metabolic Acidosis in the Intensive Care Unit (SODa-BIC): A multicentre, randomised, double- blind clinical trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- The primary outcome is MAKE30 from the date of randomisation. MAKE30 is defined as a composite of death from any cause, receipt of RRT, or persistent renal dysfunction (defined as an elevation of the creatinine level to ≥200% of baseline), all censored at hospital discharge or 30 days, whichever occurs first
研究概览
简要总结
Background: Metabolic acidosis refers to any process that elevates the concentration of hydrogen ions in the body, and is commonly encountered in critical illness. It may impair cardiac function, and sodium bicarbonate can be used to normalise blood pH. Despite being in common clinical usage, the clinical efficacy of sodium bicarbonate is still uncertain. Previous studies exploring the effects of sodium bicarbonate therapy have been limited and of variable quality.
Aim: This trial aims to assess if, among adults in the ICU with metabolic acidosis, an infusion of sodium bicarbonate diluted in 5% dextrose, compared with an infusion of 5% dextrose, reduces Major Adverse Kidney Events within 30 days of randomization.
Study Design: Phase 3, international, multicentre, double-blind, randomised clinical trial.
Participants: Adult patients (above 18 years old), admitted to the ICU within 48 hours in. select ICUs internationally, receiving a continuous infusion of a vasopressor drug to maintain a mean arterial pressure above 65 mmHg (or a mean arterial pressure target set by the treating clinician), a dedicated line (central or peripheral) is available (or is about to be made available within 1 hour after randomisation), and within two hours prior to randomisation the participant has metabolic acidosis, defined as: 1) pH less than7.30; 2) BE less than -4 mEq/L; and 3) PaCO2 less than 45 mmHg.
Intervention: Patients will be randomly allocated in a 1:1 ratio to receive two treatments that are commonly used either an infusion of 5% dextrose (D5W) + sodium bicarbonate, or D5W alone, as a comparator. Study drug will be continuously infused targeting a pH 7.30 - 7.35 and a BE more than 0 mEq/L. The infusion will be maintained until this target is achieved and continued by titration thereafter for a maximum of 5 hours (to maintain target pH and base excess levels). All other aspects of care will be determined by the treating clinical team, including the use of additional fluid therapy, vasopressors, and other organ support modalities. Open-label sodium bicarbonate bolus infusion is allowed in both groups if clinically indicated.
Primary outcome: The primary outcome is the proportion of patients who meet one or more criteria for a major adverse kidney event within 30 days (MAKE 30). MAKE 30 is a composite of death, new receipt of renal-replacement therapy, or persistent renal dysfunction (defined as a final inpatient creatinine value ≥ 200% of the baseline value). All components of MAKE30 will be censored at hospital discharge or 30 days after enrollment, whichever comes first.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •All the diagnostic criteria of metabolic acidosis below have to be fulfilled within the last 2 hours before randomisation (pH, PaCO2 and BE from the same blood gas), and a vasopressor is being infused continuously at the time of randomization.
- •Inclusion criteria 1Adults more than 18 years 2 Receiving a continuous infusion of a vasopressor to maintain mean arterial pressure above 65 mmHg (or a mean arterial pressure target set by the treating clinician) 3A dedicated intravenous line (central or peripheral) is available (or insertion of such a line is planned within the next hour)and 4Metabolic acidosis, defined as 1pH less than 7.30 and 2BE less than or equal to -4 mEq/L and 3PaCO2 less than 45 mmHg.
排除标准
- •Fulfilled all eligibility criteria greater than 48 hours ago or 2 Suspected clinically significant digestive or urinary tract loss of sodium bicarbonate ex diarrhoea, ileostomy losses, renal tubular acidosis, or drainage of pancreatic or bile duct) or 3 DKA or 4 Estimated glomerular filtration rate (eGFR) less than 30 mL/min due to chronic kidney disease or 5 Currently receiving sodium bicarbonate at the moment of randomisation (doses of sodium bicarbonate prior to randomisation are allowed) or 6 Currently receiving RRT (acute or chronic) or planned to start RRT in the next 3 hours (according to the treating clinical team) or 7 Severe dysnatraemia (serum Na above 155 mEq/L or below 120 mEq/L)or 8 Hypokalaemia (serum K below 2.5 mEq/L) or 9 Pulmonary oedema with PaO2 / FiO2 less than 100 or 10 Hypocalcaemia (iCa less than 0.8mmol/L)or 11 Patients admitted to the ICU after a drug overdose or intoxication (including alcohol intoxication)or 12 Pregnancy or breastfeeding or 13 Death is deemed to be inevitable as a result of the current acute illness and either the treating clinician, the patient or the substitute decision maker are not committed to full active treatment or 14 Patients with a life expectancy less than 30 days due to a chronic or underlying medical condition or 15 Considered to be at high risk of cerebral oedema by the treating clinician (traumatic brain injury or acute brain disease) or 16 Clinician believes that being enrolled in intervention or control arm is not in the best interest of the patient or 17 Previous enrolment in this study.
结局指标
主要结局
The primary outcome is MAKE30 from the date of randomisation. MAKE30 is defined as a composite of death from any cause, receipt of RRT, or persistent renal dysfunction (defined as an elevation of the creatinine level to ≥200% of baseline), all censored at hospital discharge or 30 days, whichever occurs first
时间窗: at hospital discharge or 30 days, whichever occurs first
次要结局
- Hospital mortality(All-cause hospital mortality at day 90)
- 30-day in-hospital mortality(30 days)
- Receipt of renal replacement therapy in the first 30 day(30 days)
- Persistent renal dysfunction(30 days)
- Renal replacement therapy dependence at day 30(Defined by the receipt of any form of renal replacement therapy within 10 days of the 30-day time point following randomisation)
- ICU mortality(All-cause ICU mortality at day 30)
- 90-day in-hospital mortality(All-cause mortality at day 90)
研究者
Dr Ary Serpa Neto
Monash university