Electrolyte ImbalanceERINCT05595395
The Enteral Resuscitation In Intensive Care Pilot- Study
A study testing Enteral Dose Form and Intravenous Infusion in people with Electrolyte Imbalance and Volume Overload, run by Medical University of Vienna at 2 sites in Austria.
Trial summary
The purpose of this pilot study is to overcome the limited evidence on enteral fluid administration in intensive care medicine and to generate data for further hypothesis generation in an exploratory setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Electrolyte Imbalance, Volume Overload, Hyperosmolality
- What is being tested?
- Enteral Dose Form and Intravenous Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 2 sitesAustria
- Study dates
- 13 Feb 2023to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient intubated within the last 72h
- Age >18 years
- Expected required fluid volume may not exceed 4 mL/kg/h (permanently, during at least 24 hours).
- Negative pregnancy test in female patients of childbearing potential
- Informed consent. For patients that are temporarily unable to consent a
- subsequent informed consent must be provided.
Who cannot join
- Evidence of severe gastrointestinal disease defined as
- Gastrointestinal Failure with > 3 symptoms (see below) or
- Lactate >3mmol/L when mesenterial ischemia is a probable cause
- Clinical signs of intra-abdominal hypertension and an increase of intra-abdominal pressure of >20 mmHg.
- Patients who cannot receive early enteral nutrition due to conditions such as prone positioning in consequence of conditions such as acute respiratory distress syndrome
- Pregnancy
Show all 17Show fewer
- Abdominal surgery in the last 3 months (unless all involved physicians, study investigators and caretaking doctors agree that the surgical event does not constitute a limitation for enteral fluid administration)
- Postoperative patients with consecutive admission to ICU
- Extracorporeal Kidney-Replacement Therapy before intubation
- At the discretion of the Investigator
- Symptoms of Gastrointestinal Failure:
- Absent bowel sounds
- Bowel distension
- Vomiting/regurgitation volume >500 ml
- GI bleeding
- Diarrhoea (liquid stool >3 times a day)
- Distended stomach on ultrasound examination.
Trial locations and contacts
2 sites in 1 country.
Austria2 sites, 2 recruiting
- Recruiting
Klinik Favoriten
Vienna, 1010
Nikolaus Keil, MD, nikolaus.keil@meduniwien.ac.at
Maximilian Waller, MD, maximilian.waller@meduniwien.ac.at
- Not yet recruiting
Department of Internal Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna, Austria
Vienna, 1090
Manfred Hecking, MD, manfred.hecking@meduniwien.ac.at
About this study
Official title: The Enteral Resuscitation In Intensive Care (ERI) Pilot- Study: Enteral Versus Intravenous Fluid Administration in the Treatment of Critically Ill Patients: a Randomized Controlled Pilot Trial
The purpose of this pilot study is to overcome the limited evidence on enteral fluid administration in intensive care medicine and to generate data for further hypothesis generation in an exploratory setting. This trial is a prospective, multicenter, randomized, parallel group, open-label study to compare the current standard of practice, the intravenous fluid administration, with a more physiological approach, the enteral fluid administration, in critically ill patients.
Read the detailed description
Introduction: The effectiveness and safety of enteral fluid administration in critically ill patients remains unclear. Existing evidence regarding this topic is scarce, but suggests that enteral fluid administration is a safe route of administration. To our knowledge no randomized controlled trial has been conducted investigating this topic.
Objectives: The aim of this pilot study is to gather evidence on the impact of enteral fluid replacement on clinical, laboratory and outcome parameters in intensive care patients in order to plan a subsequent larger randomized controlled trial. Clinical outcomes indices evaluated are regurgitation, thirst, serum sodium, mortality, length of mechanical ventilation arterial pressure, urinary volume, body weight, edema, intra-abdominal pressure), changes in bioimpedance spectroscopy-derived markers, fluid overload, renal function tests, liver function tests and SOFA-Scores.
Methods: The trial is a prospective, multicenter, randomized, parallel group, open-label study. Patients are going to be recruited and randomized at 3 separate internal medicine intensive care units in Vienna, Austria. A total of 64 patients will be recruited and randomized to receive enteral fluid administration via nasogastric tube or intravenous administration only. Daily visits and evaluation of clinical and radiological fluid status is performed by the attending physician. Regular study visits with Bioimpedance spectroscopy measurements (BIS) to evaluate fluid status are going to be performed
Results and conclusions: The ERI study will provide data on potential outcome parameters to plan a subsequent larger randomized control trial for patients receiving enteral fluid therapy in intensive care medicine.
Ethics and dissemination: The trial is performed in accordance with the Declaration of Helsinki. It subscribes to the principles outlined in the most recent version of the International Conference on Harmonization on Good Clinical Practice. Approval was obtained from the ethics committee of the Medical University of Vienna (EK number 1790/2020). The study has also been registered in a public clinical trial database (EudraCT Identifier Number 2018-002447-29, clinicaltrialsregister.eu).
- Conditions
- Electrolyte Imbalance, Volume Overload, Hyperosmolality
- Being tested
- Enteral Dose Form, Intravenous Infusion
- Keywords
- Fluid Therapy, Critical Care, Prospective Studies, Pilot Project
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral Dose FormDrug
In this intervention arm, fluid substitution is primarily done via enteral administration. The used substance for enteral fluid administered is going to be tap water. Intravenous fluid of choice is going to be "Elomel isoton".
Intravenous InfusionDrug
In this intervention arm, fluid substitution is primarily done via intravenous administration. The used substance for intravenous fluid administered is going to be "Elomel isoton".
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Fluid Arm | Placebo comparator | In Group 1 (Standard of practice/intravenous fluid group) no enteral administration of fluid other than enteral nutrition is going to be allowed. Intravenous fluid administration is going to be administered at the discretion of the physician in charge and "Elomel isoton" is going to be the fluid of choice. Receives: Drug: Intravenous Infusion |
| Enteral Fluid Arm | Active comparator | In Group 2 (Test practice/enteral fluid group) enteral fluid administration is going to be the primary mode of administration. Intravenous fluid administration can be performed by physicians at their own discretion. Primary enteral fluid administered is going to be tap water, intravenous fluid of choice is going to be "Elomel isoton". Receives: Drug: Enteral Dose Form |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regurgitation
Incidence and extent of regurgitation via the stomach/jejunal probe
Measured: From the moment of intubation to extubation.
Sodium/Osmolality
Differences of serum sodium and serum osmolality
Measured: From the moment of intubation to extubation.
Thirst
Thirst on a zero to 10 numeric rating scale (NRS; worst = 10)
Measured: On the last study visit (day of extubation)
Days on ventilation
Days on ventilation
Measured: From the moment of intubation to extubation.
30-day mortality
30-day mortality
Measured: From the moment of intubation until 30 days after intubation
Secondary outcomes (3)
Kidney Failure
Incidence and extent of kidney failure as well as kidney function
Measured: From the moment of intubation to extubation.
SOFA-Score
Differences of Sequential Organ Failure Assessment (SOFA) Scores of patients. This score includes PaO2 [mmHg], FiO2 [%], mechanical ventilation [Yes/No], Platelets [/µL], Glascow Coma Scale, Bilirubin [mg/dL], Mean arterial pressure OR administration of vasoactive agents required and creatinine [mg/dL]. The score ranges from 0=best to 24=worst.
Measured: From the moment of intubation to extubation
BCM
Differences in fluid volume status including Bioimpedance spectroscopy measurements (BIS) using Body Composition Monitor (BCM)
Measured: From the moment of intubation to extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start13 Feb 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electrolyte ImbalanceStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, explorative, multicenter, randomized, parallel group, open-label study
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Klinik Favoriten
- Responsible party
- Principal investigator, Assoc. Prof. Dr. Manfred Hecking, MD PhD, Medical University of Vienna
- Investigators
- Manfred Hecking, M.D., Principal investigator, Medical University of Vienna, Department of Nephrology and Dialysis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595395
- Sponsor's protocol ID
- EK Nr. 1790/2020
- Acronym
- ERI
- Status last verified
- Oct 2023
- First submitted
- 22 Oct 2022
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Enteral Resuscitation In Intensive Care (ERI) Pilot- Study: Enteral Versus Intravenous Fluid Administration in the Treatment of Critically Ill Patients: a Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT05595395
- Acronym / sponsor ID
- ERI / EK Nr. 1790/2020
- Conditions
- Electrolyte Imbalance, Volume Overload, Hyperosmolality
- Keywords
- Fluid Therapy, Critical Care, Prospective Studies, Pilot Project
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Klinik Favoriten
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to overcome the limited evidence on enteral fluid administration in intensive care medicine and to generate data for further hypothesis generation in an exploratory setting. This trial is a prospective, multicenter, randomized, parallel group, open-label study to compare the current standard of practice, the intravenous fluid administration, with a more physiological approach, the enteral fluid administration, in critically ill patients.
Detailed description
Introduction: The effectiveness and safety of enteral fluid administration in critically ill patients remains unclear. Existing evidence regarding this topic is scarce, but suggests that enteral fluid administration is a safe route of administration. To our knowledge no randomized controlled trial has been conducted investigating this topic.
Objectives: The aim of this pilot study is to gather evidence on the impact of enteral fluid replacement on clinical, laboratory and outcome parameters in intensive care patients in order to plan a subsequent larger randomized controlled trial. Clinical outcomes indices evaluated are regurgitation, thirst, serum sodium, mortality, length of mechanical ventilation arterial pressure, urinary volume, body weight, edema, intra-abdominal pressure), changes in bioimpedance spectroscopy-derived markers, fluid overload, renal function tests, liver function tests and SOFA-Scores.
Methods: The trial is a prospective, multicenter, randomized, parallel group, open-label study. Patients are going to be recruited and randomized at 3 separate internal medicine intensive care units in Vienna, Austria. A total of 64 patients will be recruited and randomized to receive enteral fluid administration via nasogastric tube or intravenous administration only. Daily visits and evaluation of clinical and radiological fluid status is performed by the attending physician. Regular study visits with Bioimpedance spectroscopy measurements (BIS) to evaluate fluid status are going to be performed
Results and conclusions: The ERI study will provide data on potential outcome parameters to plan a subsequent larger randomized control trial for patients receiving enteral fluid therapy in intensive care medicine.
Ethics and dissemination: The trial is performed in accordance with the Declaration of Helsinki. It subscribes to the principles outlined in the most recent version of the International Conference on Harmonization on Good Clinical Practice. Approval was obtained from the ethics committee of the Medical University of Vienna (EK number 1790/2020). The study has also been registered in a public clinical trial database (EudraCT Identifier Number 2018-002447-29, clinicaltrialsregister.eu).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, explorative, multicenter, randomized, parallel group, open-label study
| Arm | Type | Receives |
|---|---|---|
| Intravenous Fluid Arm | Placebo comparator | Drug: Intravenous InfusionIn Group 1 (Standard of practice/intravenous fluid group) no enteral administration of fluid other than enteral nutrition is going to be allowed. Intravenous fluid administration is going to be administered at the discretion of the physician in charge and "Elomel isoton" is going to be the fluid of choice. |
| Enteral Fluid Arm | Active comparator | Drug: Enteral Dose FormIn Group 2 (Test practice/enteral fluid group) enteral fluid administration is going to be the primary mode of administration. Intravenous fluid administration can be performed by physicians at their own discretion. Primary enteral fluid administered is going to be tap water, intravenous fluid of choice is going to be "Elomel isoton". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
Key exclusion criteria (17 listed)
- Absent bowel sounds
- Bowel distension
- Vomiting/regurgitation volume >500 ml
- GI bleeding
- Diarrhoea (liquid stool >3 times a day)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enteral Dose FormIn this intervention arm, fluid substitution is primarily done via enteral administration. The used substance for enteral fluid administered is going to be tap water. Intravenous fluid of choice is going to be "Elomel isoton". | Drug | Enteral Fluid Arm |
| Intravenous InfusionIn this intervention arm, fluid substitution is primarily done via intravenous administration. The used substance for intravenous fluid administered is going to be "Elomel isoton". | Drug | Intravenous Fluid Arm |
Primary outcome
Regurgitation
Time frame: From the moment of intubation to extubation.
Incidence and extent of regurgitation via the stomach/jejunal probe
Sodium/Osmolality
Time frame: From the moment of intubation to extubation.
Differences of serum sodium and serum osmolality
Thirst
Time frame: On the last study visit (day of extubation)
Thirst on a zero to 10 numeric rating scale (NRS; worst = 10)
Days on ventilation
Time frame: From the moment of intubation to extubation.
Days on ventilation
30-day mortality
Time frame: From the moment of intubation until 30 days after intubation
30-day mortality
3 secondary outcomes
Kidney Failure
Time frame: From the moment of intubation to extubation.
SOFA-Score
Time frame: From the moment of intubation to extubation
BCM
Time frame: From the moment of intubation to extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manfred Hecking, M.D. principal investigator
Medical University of Vienna, Department of Nephrology and Dialysis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enteral Dose Form and Intravenous Infusion in people with Electrolyte Imbalance and Volume Overload, run by Medical University of Vienna at 2 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manfred Hecking, MD, PhD (0043-699-10580831, manfred.hecking@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regurgitation (time frame: From the moment of intubation to extubation.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.