Sodium bicarbonate for critically ill patients with metabolic acidosis and AKI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 4 interventional study enrolling critically ill adults with metabolic acidosis and acute kidney injury (KDIGO stage 2-3). Participants receive either an 8.4% sodium bicarbonate injection or a balanced crystalloid as part of standard ICU care, with outcomes focused on major adverse kidney events by day 90. The trial aims to provide high-quality evidence about the potential kidney- and survival-related benefits of correcting acidosis in this high-risk population. Eligibility includes adults in ICUs with defined acid-base criteria and AKI, excluding those with pregnancy, preexisting end-stage kidney disease, or immediate need for kidney replacement therapy. The study is led by Universität Münster with German Research Foundation collaboration and sites at University Münster and University Hospital Münster.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adult ≥ 18 years
2. Critically ill patients (requiring treatment on an ICU or IMC)
3. Metabolic acidosis, defined as all of the following:

   1. Arterial pH ≤7.25
   2. PaCO2 \< 6.5kPa (\<49 mmHg)
   3. Standard bicarbonate ≤20 mmol/L
   4. Standard Base Excess \<-2
4. AKI stage 2 or 3 of the KDIGO classification
5. Written informed consent of the patient or legal representative or authorized representative or emergency inclusion (according to Article 35 EU-Regulation 536/2014)

Exclusion Criteria:

1. Pregnant or breastfeeding patients
2. Respiratory acidosis (acute or chronic) \[dynamic, and if corrected, patient may be reconsidered for the trial\]
3. Patients on KRT, or KRT immediately indicated and treating clinician(s) unwilling to defer
4. Deemed unsuitable for KRT
5. High output stoma/ileostomy
6. Percutaneous biliary drainage
7. End stage kidney failure defined as documented eGFR \<15ml/min/1.73m 2 prior to onset of this acute illness or end stage kidney disease (ESKD) on dialysis
8. Known renal tubular acidosis
9. Diabetic ketoacidosis
10. High anion gap acid poisoning (e.g. polyethylene glycol (PEG), aspirin, methanol)
11. Symptomatic hypocalcaemia (Ionized calcium \<1.05 mmol/L)\[dynamic, and if corrected, patient may be reconsidered for the trial\]
12. Hypernatremia (plasma sodium \>150 mmol/L)\[dynamic, and if corrected, patient may be reconsidered for the trial\]
13. Severe hypokalemia (potassium \<3.0 mmol/L)\[dynamic, and if corrected, patient may be reconsidered for the trial\]
14. Death perceived as imminent
15. Known hypersensitivity to sodium bicarbonate or EDTA (Disodiumedetate)
16. Previously randomized into ESCALATE

Where it's running

• University Münster, University Hospital Münster
  Münster, Germany Recruiting

Study contacts

• Study coordinator: Alexander Zarbock, MD
• Email: ESCALATE@ukmuenster.de
• Phone: +49251-8347255

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.