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临床试验/ISRCTN14027629
ISRCTN14027629进行中（未招募）4 期

Evaluating the clinical and cost-effectiveness of sodium bicarbonate administration for critically ill patients with acute kidney injury and metabolic acidosis

niversity Hospitals of Derby and Burton NHS Foundation Trust0 个研究点目标入组 2,250 人开始时间: 2021年7月27日最近更新:
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试验速览

阶段
4 期
状态
进行中（未招募）
发起方
入组人数
2,250
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • •Current inclusion criteria as of 19/12/2022:
  • •1. Adult (aged =18 years)
  • •2. Metabolic acidosis (defined by arterial blood gas values of pH <7.30 and PaCO2 <6.5 kPa)
  • •3. AKI – categorised as stage 2 or 3 of the Kidney Disease Improving: Global Outcomes (KDIGO) classification, defined as any one of the following three criteria:
  • •Serum creatinine =2.0 times baseline*
  • •Serum creatinine =354 µmol/L, AND
  • •either a rise of =27 µmol/L within 48 hours or serum creatinine =1.5 times baseline*
  • •Urine output of <0.5 ml/kg/h for =12 hours
  • •*For baseline serum creatinine value:
  • •If available, then use pre-hospitalisation value within 365 days of the current hospital admission date.
  • •If there are multiple pre-hospitalisation values, then use the one closest to the date of the current hospital admission.
  • •If a pre-hospitalisation value from the 365 days prior to admission date is not available and there are multiple serum creatinine values from the current hospitalisation, then use the lowest one from the current hospitalisation.
  • •If no baseline serum creatinine value is available, then estimate it using the provided calculator.
  • •Previous inclusion criteria:
  • •1. Adult (aged =18 years)
  • •2. Metabolic acidosis (defined by arterial blood gas values of pH <7.25, PaCO2 <6.5 kPa and bicarbonate =20 mmol/L)
  • •3. AKI – categorised as stage 2 or 3 of the Kidney Disease Improving: Global Outcomes (KDIGO) classification, defined as any one of the following three criteria:
  • •Serum creatinine =2.0 times baseline*
  • •Serum creatinine =354 µmol/L, AND either a rise of =27 µmol/L within 48 hours or serum creatinine =1.5 times baseline*
  • •Urine output of <0.5 ml/kg/h for =12 hours
  • •*For baseline serum creatinine value:
  • •If available, then use pre-hospitalisation value within 365 days of the current hospital admission date.
  • •If there are multiple pre-hospitalisation values, then use the one closest to the date of the current hospital admission.
  • •If a pre-hospitalisation value from the 365 days prior to admission date is not available and there are multiple serum creatinine values from the current hospitalisation, then use the lowest one from the current hospitalisation as the baseline value.
  • •If no baseline serum creatinine value is available, then estimate it using the provided calculator.

排除标准

  • •Current exclusion criteria as of 19/12/2022:
  • •1. Respiratory acidosis (acute or chronic)
  • •2. Kidney replacement therapy (KRT) immediately indicated and treating clinician(s) unwilling to defer if randomised to sodium bicarbonate
  • •3. Deemed unsuitable for KRT
  • •4. High output stoma/ileostomy
  • •5. Percutaneous biliary drainage
  • •6. End stage kidney failure defined as documented eGFR<15 ml/min/1.73m² prior to onset of this acute illness or end stage kidney disease (ESKD) on dialysis
  • •7. Known renal tubular acidosis
  • •8. Diabetic ketoacidosis
  • •9. High anion gap acid poisoning (e.g. polyethylene glycol (PEG), aspirin, methanol)
  • •10. Symptomatic hypocalcaemia (Ionised calcium <1.05 mmol/L) †
  • •11. Hypernatraemia (Plasma sodium >150 mmol/L) †
  • •12. Severe hypokalaemia (Potassium <3.0 mmol/L) †
  • •13. Death perceived as imminent
  • •14. Known hypersensitivity to sodium bicarbonate or to any of the excipients listed in section 6.1 of the SmPC
  • •15. Previously randomised into MOSAICC
  • •† Exclusion criteria 10-12 are dynamic, and if corrected, patient may be reconsidered for the trial.
  • •Previous participant exclusion criteria as of 28/04/2022:
  • •1. Respiratory acidosis (acute or chronic)
  • •2. Clinical decision already in place to start patient on kidney replacement therapy (KRT)
  • •3. Deemed unsuitable for KRT
  • •4. High output stoma/ileostomy
  • •5. Percutaneous biliary drainage
  • •6. Documented eGFR<15 ml/min/1.73 m² or end stage kidney disease (ESKD) on dialysis
  • •7. Known renal tubular acidosis
  • •8. Diabetic ketoacidosis
  • •9. High anion gap acid poisoning (e.g. polyethylene glycol (PEG), aspirin, methanol)
  • •10. Symptomatic hypocalcaemia (Ionised calcium <1.05 mmol/l)†
  • •11. Hypernatraemia (Plasma sodium >150 mmol/l)†
  • •12. Severe hypokalaemia (Potassium <3.0 mmol/l)†
  • •13. Death perceived as imminent
  • •14. Known hypersensitivity to sodium bicarbonate or to any of the excipients listed in section 6.1 of the SmPC
  • •15. Previously randomised into MOSAICC
  • •† Exclusion criteria 10-12 are dynamic, and if corrected, the patient may be reconsidered for the trial.
  • •Previous participant exclusion criteria as of 02/11/2021:
  • •1. Respiratory acidosis (acute or chronic)
  • •2. Clinical decision already in place to start the patient on kidney replacement therapy (KRT)
  • •3. Deemed unsuitable for KRT
  • •4. Acute diarrhoea, including high output stoma/ileostomy
  • •5. Percutaneous biliary drainage
  • •6. Documented Stage 4 chronic kidney disease (CKD) [eGFR <30 ml/min/1.73m2] or end-stage kidney disease (ESKD) on dialysis
  • •7. Known renal tubular acidosis
  • •8. Diabetic ketoacidosis
  • •9. High anion gap acid poisoning (e.g. polyethylene glycol (PEG), aspirin, methanol)
  • •10. Known to be pregnant
  • •11. Symptomatic hypocalcaemia (Ionised calcium <1.05 mmol/L)†
  • •12. Hypernatraemia (Plasma sodium >150 mmol/L)†
  • •13. Severe hypokalaemia (Potassium <3.0 mmol/L)†
  • •14. Solid organ transplant
  • •15. Death perceived as imminent
  • 另有 9 项未显示

研究者

发起方
niversity Hospitals of Derby and Burton NHS Foundation Trust

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