A Phase 4 interventional study of Sodium Bicarbonate 8.4% Solution for Injection and Balanced crystalloid solution in Acute Kidney Injury, Metabolic Acidosis and Critical Illness, sponsored by Universität Münster. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Universität Münster · Phase 4, Interventional, and Treatment
The study investigates whether sodium bicarbonate is able to reduce the occurrence of major adverse kidney events on day 90 (MAKE90) in critically ill patients with metabolic acidosis and acute kidney injury (AKI). While its efficacy in this context has been suggested in a subgroup analysis of the BICAR-ICU trial it has not been confirmed in a double-blinded randomized controlled trial to date.
Each year > 200 000 adult patients are admitted to intensive-care units (ICUs) in Germany of which around half develop acute kidney injury (AKI). AKI markedly increases morbidity, mortality, ICU/hospital length of stay, and the risk of progression to chronic kidney disease.2-4 Metabolic acidosis significantly raises hospital mortality, the need for kidney-replacement therapy (KRT), and the incidence of major adverse kidney events within 30 days (MAKE30).5,6 When AKI and metabolic acidosis coexist, 90-day mortality ranges from 53 % to 59 % (vs 26 % for AKI alone).
Acidaemia depresses cardiovascular function through reduced myocardial contractility, impaired catecholamine responsiveness, hyperkalaemia, pulmonary vasoconstriction and arrhythmogenesis.7,8 Restoring extracellular pH is therefore biologically plausible as a strategy to improve organ perfusion and outcomes.
Sodium bicarbonate is the most widely used buffer in clinical practice, yet high-quality evidence for its benefit in AKI with metabolic acidosis is lacking. To date, despite numerous calls for appropriately designed studies, there have only been two RCTs primarily addressing the effects of sodium bicarbonate in critically ill patients with severe acidosis.1,9 Due to methodological limitations (open-label study design, selection bias, risk of confounding) and lack in generalizability, the question on using sodium bicarbonate in critically ill patients with AKI and metabolic acidosis cannot be answered with certainty.
The "Evaluating the clinical effectiveness of sodium bicarbonate for critically ill patients with metabolic acidosis and acute kidney injury" trial is a multicenter, double-blinded, randomized controlled trial. It is designed to determine whether treatment with intravenous 8.4% weight/volume (w/v) sodium bicarbonate is superior to placebo in terms of the composite endpoint major adverse kidney events (MAKE) at day 90 (composite of death from any cause, receipt of any KRT within the 90-day period, or persistent renal dysfunction (defined as a creatinine value ≥200% of the baseline value) at day 90) in critically ill patients with AKI (KDIGO stage 2 or 3) and metabolic acidosis. The findings of the ESCALATE trial are expected to have significant implications for clinical practice and patient outcomes, both in Germany and internationally, by providing high-quality evidence to guide the management of a critically ill population with high risk of mortality.
1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.
This study's planned enrollment of 660 is above the median of 100 across 817 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Universität Münster is the lead sponsor of 30 studies on the registry; 19 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Metabolic acidosis, defined as all of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Experimental: Sodium Bicarbonate 8.4% w/v Intravenous infusion according to the treatment algorithm targeting a pH\>7.30
Drug: Sodium Bicarbonate 8.4% Solution for Injection
Placebo: Balanced crystalloid solution Intravenous infusion according to the treatment algorithm targeting a pH\>7.30
Drug: Balanced crystalloid solution
Intravenous infusion according to the treatment algorithm. Infusion starts with 100ml/hr until a pH of 7.30 - 7.35 and a Base Excess of ≥ 0 is reached. Then, infusion is reduced to 25ml/hr and maintained for 5 hours. After 5 hours, infusion is titrated to a pH of \>7.30.
Intravenous infusion according to the treatment algorithm. Infusion starts with 100ml/hr until a pH of 7.30 - 7.35 and a Base Excess of ≥ 0 is reached. Then, infusion is reduced to 25ml/hr and maintained for 5 hours. After 5 hours, infusion is titrated to a pH of \>7.30.
MAKE90 (consisting of mortality, dialysis within 90 days, persistent renal dysfunction (defined as serum creatinine ≥ 2x compared to baseline value at day 90)
Time frame: 90 days after randomization
90-day all-cause mortality (%)
Time frame: 90 days after randomization
Elevation of the creatinine level to ≥200% of base value at day 90 (one measurement between day 80 and 120 after randomization)
Time frame: 80 - 120 days after randomization
Receipt of any form of KRT within the 90-day time period after randomization
Time frame: 90 days after randomization
KRT-dependence on day 90
Time frame: 90 days after randomization
KRT-free days, defined as difference between number of days receiving KRT of any form between randomization and day 90 and number of days alive
Time frame: 90 days after randomization
ICU-Mortality (%)
Time frame: 90 days after randomization
Hospital Mortality (%)
Time frame: 90 days after randomization
Incidence of suspected unexpected serious adverse reactions (SUSARs)
Time frame: from randomization until the end of treatment phase (up to day 7 OR Discharge from the intensive care unit, whatever comes first
KRT-free days up to day 28
Time frame: 28 days after randomization
Vasopressor-free days up to day 28
Time frame: 28 days after randomization
Vasopressor-free days up to day 90
Time frame: 90 days after randomization
Ventilator-free days up to day 28
Time frame: 28 days after randomization
Total hospital-free days up to day 90
Time frame: 90 days after randomization
Change in eGFR between baseline and day 90
Time frame: 90 days after randomization
Incidence of hospital acquired infections during ICU-stay
Time frame: within initial ICU stay (up to 90 days after randomization)
Plan to share: Yes — Individual participant data that underlie the results reported in this study, after deidentification (text, tables, figures, and appendices)
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Beginning 9 months and ending 36 months following article publication
Access criteria: With whom? Researchers who provide a methodologically sound proposal By what mechanism will data be made available? Proposals should be directed to ESCALATE@ukmuenster.de. To gain access, data requestors will need to sign a data access agreement.
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Studies of the drug tested here: Sodium Bicarbonate
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