ACTRN12620001361998终止2 期
SODium BICarbonate for metabolic acidosis in the Intensive Care Unit: A pilot, multicentre, randomized, double-blind clinical trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 30
研究概览
简要总结
In patients with metabolic acidosis (acid blood) the use of sodium bicarbonate was not associated with shorter duration of vasopressore infusion (drug to increase blood pressure). However, the use of sodium bicarbonate reduced the time until the correction of the blood pH (acidosis). These findings confirm that a larger study is feasible and needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •The target population is vasopressor-dependent, adult critically ill patients, with moderate metabolic acidosis.
- •All the diagnostic criteria of moderate metabolic acidosis below have to be fulfilled within the last 2 hours before randomization, and a vasopressor is being infused continuously at the time of randomization.
- •1.Adult patients (>= 18 years);
- •2.Patient is within 48 hours of admission to the ICU;
- •3.Patient is receiving a continuous infusion of a vasopressor drug to maintain mean arterial pressure > 65 mmHg;
- •4.A dedicated line (central or peripheric) is available (or is about to be made available within 1 hour after randomization); and
- •5.Patient has at least a moderate metabolic acidosis, defined as:
- •a.pH < 7.30; and
- •b.BE < -4 mEq/L; and
- •c.PaCO2 < 45 mmHg.
排除标准
- •1. Proven digestive or urinary tract loss of sodium bicarbonate (e.g., acute diarrhoea, ileostomy, or drainage of pancreatic or biliary duct); or
- •2. DKA; or
- •3. Stage IV or V chronic kidney disease; or
- •4. Using renal replacement therapy (acute or chronic); or
- •5. Received sodium bicarbonate within 24 hours of screening; or
- •6. Dysnatraemia (serum Na greater than or equal to 155 mEq/L or < 120 mEq/L); or
- •7. Hypokalaemia (serum K < 2.5 mEq/L); or
- •8. Pulmonary oedema with PaO2 / FiO2 < 100; or
- •9. Hypocalcaemia (iCa < 0.8mmol/L); or
- •10. Known or suspected poisoning of antidepressant or antipsychotic poisoning agents that may cause high anion gap acidosis (methanol, PEG, aspirin); or
- •11. Suspected intoxication with unknown aetiology; or
- •12. Pregnancy or breastfeeding; or
- •13. Limitation of medical therapy orders (DNR, DNI); or
- •14. Imminent or inevitable death; or
- •15. In the opinion of the treating clinical team the patients will almost certainly receive RRT in the next 6 hours; or
- •16. Traumatic brain injury (or substantial risk for intracranial hypertension); or
- •17. Clinician believes that being enrolled in intervention or control arm is not in the best interest of the patient; or
- •18. Previous enrolment in this study ever.
研究者
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