Clinical trial • Phase IV • Nephrology|Endocrinology

SODIUM HYDROGEN CARBONATE for Metabolic acidosis|Acute kidney injury|Critical illness

Phase IV trial of SODIUM HYDROGEN CARBONATE for Metabolic acidosis|Acute kidney injury|Critical illness.

Overview

Trial Therapeutic Area
Nephrology|Endocrinology
Trial Disease
Metabolic acidosis|Acute kidney injury|Critical illness
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
11-12-2025
First CTIS Authorization Date
17-03-2026

Trial design

Randomised, arms: sodium bicarbonate 8.4% (w/v) (intervention) and balanced crystalloid (e.g. sterofundin iso) (comparator). no specific dose/schedule beyond intravenous infusion are specified in the provided record.-controlled, adaptive Phase IV trial in Germany.

Randomised
Yes
Comparator
Arms: Sodium bicarbonate 8.4% (w/v) (intervention) and Balanced crystalloid (e.g. Sterofundin ISO) (comparator). No specific dose/schedule beyond intravenous infusion are specified in the provided record.
Adaptive
True, includes interim analysis with planned enrolment approximately 660 patients with potential increase up to 760 patients based on interim analysis (ESCALATE allocation and interim analysis).
Biomarker Stratified
True, pH (<7.20 or > 7.20) and AKI stage (AKI stage 2 or AKI stage 3)
Target Sample Size
660
Trial Duration For Participant
90

Stratification factors

  • Site
  • pH (<7.20 or > 7.20)
  • AKI stage (AKI stage 2 or AKI stage 3)

Eligibility

Recruits 660 Vulnerable populations are selected. Written informed consent may be provided by the patient or by a legal representative or authorized representative; emergency inclusion is allowed according to Article 35 EU-Regulation 536/2014. Separate subject information and informed consent forms for patients and legal guardians (prospective and retrospective) are provided..

Vulnerable Population
Vulnerable populations are selected. Written informed consent may be provided by the patient or by a legal representative or authorized representative; emergency inclusion is allowed according to Article 35 EU-Regulation 536/2014. Separate subject information and informed consent forms for patients and legal guardians (prospective and retrospective) are provided.

Inclusion criteria

  • {"criterion_text":"- Adult ≥ 18 years\n- Critically ill patients (requiring treatment on an Intensive Care Unit or Intermediate Care Unit)\n- Metabolic acidosis, defined as all of the following: a.\tArterial pH ≤ 7.25 b.\tPaCO2 < 6.5kPa (<49 mmHg) c.\tStandard bicarbonate ≤ 20 mmol/L d.\tStandard Base Excess <-2\n- AKI stage 2 or 3 of the KDIGO classification\n- 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

  • {"criterion_text":"- Respiratory acidosis (acute or chronic)\n- Symptomatic hypocalcaemia (Ionized calcium <1.05 mmol/L)\n- Hypernatremia (plasma sodium >150 mmol/L)\n- Severe hypokalemia (potassium <3.0 mmol/L)\n- Patients on KRT, or KRT immediately indicated and treating clinician(s) unwilling to defer\n- Deemed unsuitable for KRT\n- High output stoma/ileostomy\n- Percutaneous biliary drainage\n- End stage kidney failure defined as documented eGFR <15ml/min/1.73m2 prior to onset of this acute illness or end stage kidney disease (ESKD) on dialysi\n- Known renal tubular acidosis\n- Diabetic ketoacidosis\n- High anion gap acid poisoning (e.g. polyethylene glycol (PEG), aspirin, methanol)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Major adverse kidney events (MAKE90) Binary endpoint consisting of mortality or any KRT within 90 days after randomization or persistent renal dysfunction (creatinine value at day 90 ≥200% of baseline value) at day 90","definition_or_measurement_approach":"Binary endpoint consisting of mortality or any KRT within 90 days after randomization or persistent renal dysfunction (creatinine value at day 90 ≥200% of baseline value) at day 90"}

Secondary endpoints

  • {"endpoint_text":"- 90-day all-cause mortality (%)","definition_or_measurement_approach":"All-cause mortality assessed at day 90 after randomization"}
  • {"endpoint_text":"- Elevation of the creatinine level to ≥200% of baseline value at day 90 (one measurement between day 80 and 120 after randomization)","definition_or_measurement_approach":"Single creatinine measurement between day 80 and 120 after randomization to assess elevation to ≥200% of baseline at day 90"}
  • {"endpoint_text":"- Receipt of any form of KRT within the 90-day time period after randomization","definition_or_measurement_approach":"Receipt of any form of kidney replacement therapy documented within 90 days after randomization"}
  • {"endpoint_text":"- Kidney Replacement Therapy (KRT)-dependence at day 90 after randomization","definition_or_measurement_approach":"Assessment of dependence on KRT at day 90 after randomization"}
  • {"endpoint_text":"- KRT-free days, defined as difference between number of days alive and number of days receiving KRT of any form between randomization and day 90","definition_or_measurement_approach":"Calculated as days alive minus days receiving any form of KRT between randomization and day 90"}

Recruitment

Planned Sample Size
660
Recruitment Window Months
3
Consent Approach
Written informed consent required from the patient or from a legal representative or authorized representative; emergency inclusion per Article 35 EU-Regulation 536/2014 is permitted. Separate information and informed consent forms for patients and legal guardians (prospective and retrospective) are provided. Languages available are not specified.

Geography

Total Number Of Sites
21
Total Number Of Participants
660

Germany

Earliest CTIS Part Ii Submission Date
26-02-2026
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
19
Number Of Sites
21
Number Of Participants
660

Sites

Site Name
Universitaetsklinikum Bonn AöR
Department Name
Klinik und Poliklinik für Anästhesiologie und Operative Intensivmedizin
Contact Person Name
Christian Putensen
Contact Person Email
studienzentrale-szb@ukbonn.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Nephrology and Medical Intensive Care
Contact Person Name
Philipp Enghard
Contact Person Email
philipp.enghard@charite.de
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Klinik für Operative Intensivmedizin und Intermediate Care
Contact Person Name
Tim-Philipp Simon
Contact Person Email
tsimon@ukaachen.de
Site Name
Evangelisches Klinikum Bethel gGmbH
Department Name
Universitätsklinik für Anästh, Intensiv-, Notfallmedizin, Transfusionsmedizin und Schmerzth
Contact Person Name
Rainer Borgstedt
Contact Person Email
rainer.borgstedt@evkb.de
Site Name
Universitaet Muenster
Department Name
Klinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie
Contact Person Name
Alexander Zarbock
Contact Person Email
zarbock@uni-muenster.de
Site Name
Universitaetsklinikum Leipzig AöR
Department Name
Department of Anaesthesiology and Intensive Care
Contact Person Name
Stefan Schering
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
Department of Anaesthesiology
Contact Person Name
Eva-Marie Griemert
Site Name
Klinikum Dortmund gGmbH
Department Name
Klinik für Anästhesiologie
Contact Person Name
Richard Ellerkmann
Site Name
LMU Klinikum Muenchen AöR
Department Name
Klinik für Anaesthesiologie
Contact Person Name
Christina Scharf-Janßen
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Klinik für Intensivmedizin
Contact Person Name
Stefan Kluge
Contact Person Email
s.kluge@uke.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Department of Anesthesiology and Intensive Care Medicine Crona Kliniken
Contact Person Name
Peter Rosenberger
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Klinik und Poliklinik für Anästhesiologie, Intensivmedizin, Notfallmedizin und Schmerztherapie
Contact Person Name
Patrick Meybohm
Contact Person Email
Meybohm_P@ukw.de
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Anesthesiology and Critical Care Medicine
Contact Person Name
Andreas Güldner
Contact Person Email
andreas.gueldner@ukdd.de
Site Name
Universitaetsklinikum Augsburg
Department Name
Department of Anesthesiology and Intensive Care Medicine
Contact Person Name
Philipp Simon
Contact Person Email
philipp.simon3@uk-augsburg.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Medizinische Klinik 4
Contact Person Name
Carsten Willam
Contact Person Email
carsten.willam@uk-erlangen.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Department of Anesthesiology and Intensive Care
Contact Person Name
Thorsten Brenner
Contact Person Email
thorsten.brenner@uk-essen.de
Site Name
Klinikum Bayreuth GmbH
Department Name
Department of Anesthesiology and Intensive Care Medicine
Contact Person Name
Jörg Reutershan
Site Name
Rostock University Medical Center
Department Name
Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy
Contact Person Name
Jens-Christian Schewe
Site Name
Charite Universitaetsmedizin Berlin KöR (Chariteplatz address)
Department Name
Nephrology and Medical Intensive Care
Contact Person Name
Philipp Enghard
Contact Person Email
Philipp.Enghard@Charite.de
Site Name
Medizinische Hochschule Hannover
Department Name
Department of Anaesthesiology and Intensive Care
Contact Person Name
Hans-Jörg Gillmann
Site Name
Evangelisches Klinikum Bethel gGmbH (Burgsteig address)
Department Name
Universitätsklinik für Anästh, Intensiv-, Notfallmedizin, Transfusionsmedizin und Schmerzth
Contact Person Name
Rainer Borgstedt
Contact Person Email
rainer.borgstedt@evkb.de

Sponsor

Primary sponsor

Full Name
Universitaet Muenster
Organisation Type
Educational Institution
Country Of Registered Address
Germany

Third parties

  • {"country":"","full_name":"German Research Foundation (Deutsche Forschungsgemeinschaft, DFG)","duties_or_roles":"Monetary support","organisation_type":""}

Investigational products

Investigational Product Name
SODIUM HYDROGEN CARBONATE
Active Substance
SODIUM HYDROGEN CARBONATE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS PERFUSION USE
Route
Intravenous infusion
Investigational Product Name
Jonosteril Infusionslösung
Active Substance
sodium chloride, calcium acetate, magnesium acetate tetrahydrate, potassium acetate, sodium acetate trihydrate
Modality
Small molecule
Routes Of Administration
INTRAVENOUS PERFUSION USE
Route
Intravenous infusion
Authorisation Status
Marketing authorisation number: 6100285.00.00
Investigational Product Name
Elektrolyt-Infusionslösung 153
Active Substance
magnesium chloride hexahydrate, potassium chloride, sodium chloride, calcium chloride dihydrate, sodium acetate trihydrate
Modality
Small molecule
Routes Of Administration
INTRAVENOUS PERFUSION USE
Route
Intravenous infusion
Authorisation Status
Marketing authorisation number: 3000181.00.00
Investigational Product Name
Sterofundin ISO Infusionslösung
Active Substance
magnesium chloride hexahydrate, potassium chloride, sodium chloride, calcium chloride dihydrate, malic acid, sodium acetate trihydrate
Modality
Small molecule
Routes Of Administration
INTRAVENOUS PERFUSION USE
Route
Intravenous infusion
Authorisation Status
Marketing authorisation number: 60452.00.00
Investigational Product Name
Ringer-Infusionslösung B. Braun
Active Substance
potassium chloride, sodium chloride, calcium chloride dihydrate
Modality
Small molecule
Routes Of Administration
INTRAVENOUS PERFUSION USE
Route
Intravenous infusion
Authorisation Status
Marketing authorisation number: 6737462.00.01

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