Critical IllnessPhase 4NCT03992716
Reaching Protein Target With SmofKabiven® Extra Nitrogen vs Olimel N9E During the Early Phase of Acute Critical Illness
A Phase 4 study testing SmofKabiven® extra Nitrogen and Olimel N9E in people with Critical Illness, run by Fresenius Kabi at 3 sites in 3 countries.
Trial summary
The main focus of the study is to show that SmofKabiven® extra Nitrogen, in a realistic clinical setting, enables to meet high protein requirements in patients during the first week after onset of critical illness, without risk of overfeeding with energy. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- SmofKabiven® extra Nitrogen and Olimel N9E
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 26 Nov 2019to 24 Mar 2020
- Phase
- Phase 4
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years and <90 years, male and female
- Critically ill, medical or surgical ICU patient
- Admitted to the ICU on the same day or the day before with a minimum expected ICU stay of 3 days
- Central venous access available for continuous infusion of the study drugs
- Sequential Organ Failure Assessment (SOFA) score ≥2
- Contraindication against enteral nutrition or limited tolerance to enteral nutrition and it is planned that patient receives ≥80% of the total target caloric intake from parenteral nutrition during the first 3 nutritional treatment days
- Written informed consent from the patient or the patient's legal representative or deferred written consent from the patient or patient's legal representative (deferred proxy consent)
Who cannot join
- Contraindication against parenteral nutrition or inability to receive parenteral nutrition via central venous access
- Received parenteral nutrition within 7 days before randomisation
- It is planned that patient receives ≥20% of the total target caloric intake via enteral or oral nutrition and/or non-nutritional sources (glucose solution for drug dilution or lipids from propofol/clevidipine or citrate from continuous renal replacement therapy) during the first 3 nutritional treatment days
- Body mass index (BMI) <18.5 kg/m2 or >35 kg/m2
- Burn injury
- Any severe, persistent blood coagulation disorder with uncontrolled bleeding
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- Any congenital errors of amino acid metabolism
- Uncontrolled hyperglycaemia despite insulin treatment
- Known hypersensitivity to fish, egg, soybean proteins, peanut proteins, or to any of the active substances or excipients contained in SmofKabiven® extra Nitrogen or Olimel N9E
- Known hypersensitivity to milk protein or to any other substance contained in Fresubin® Original
- Treatment-refractory cardiopulmonary or metabolic instability showing persistent or progressive worsening despite increased interventions, including severe pulmonary oedema, severe cardiac insufficiency, myocardial infarction, acute phase of circulatory shock, severe sepsis, embolism, haemodynamic instability, metabolic or respiratory acidosis, hypotonic dehydration, or hyperosmolar coma
- Severe renal dysfunction, defined as serum creatinine ≥2.0 times baseline or urine output <0.5 mL/kg/h for ≥12 hours (Acute Kidney Injury stage ≥2; [KDIGO 2012]), and blood urea nitrogen (BUN) exceeding 2 x upper limit of normal (ULN)
- Severe liver failure with encephalopathy, including intoxication (e.g. paracetamol, death cap, golden chain) and/or liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma glutamyl transferase [GGT]) or bilirubin exceeding 5 x ULN
- Oncologic disease with anticancer drug and/or radiation treatment incl. Hyperthermic Intraperitoneal Chemotherapy (HIPEC) during this Trial up to and including Study Day 28
- Preceding transplantation causal for acute critical illness
- Hemophagocytic syndrome
- Pregnancy or lactation
- Receiving end-of-life-care
- Pathologically altered blood pH (arterial pH <7.0), oxygen saturation (SaO2 <80%), or carbon dioxide concentration (PaCO2 ≥80 mm Hg)
- Hyperlipidaemia or any disorder of lipid metabolism characterised by hypertriglyceridaemia (serum triglyceride levels >4 mmol/L [>350 mg/dL])
- Treatment-refractory, clinically significant major abnormality in the serum concentration of any electrolyte (sodium, potassium, magnesium, total calcium, chloride, inorganic phosphate)
- Administration of growth hormone including teduglutide within the previous 4 weeks before randomisation
- Invasive devices and procedures influencing metabolism and organ perfusion, e.g. extracorporeal membrane oxygenation (ECMO), continuous renal replacement therapy (CRRT), molecular absorbent recycling system (MARS), intra-aortic balloon pump (IABP)
- Receipt of the last dose of study drug in another interventional clinical trial within the previous 4 weeks before randomisation into this clinical trial
- Previous inclusion in the present study
- Any other known reason that may prevent a patient to take part in the study in accordance with local requirements
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
France1 site
Hôpital Saint-Antoine, Département d'Anesthésie-Réanimation
Paris, 75012
Germany1 site
Klinikum rechts der Isar, Klinik für Anaesthesiologie
München, 81675
Poland1 site
SP ZOZ Wojewódzki Szpital Zespolony im. J. Śniadeckiego
Bialystok, 15-897
About this study
Official title: Reaching Protein Target With SmofKabiven® Extra Nitrogen Versus Olimel N9E: A Prospective, Randomised, Active-controlled, Patient-blinded, Multicentre Clinical Trial During the Early Phase of Acute Critical Illness
The main focus of the study is to show that SmofKabiven® extra Nitrogen, in a realistic clinical setting, enables to meet high protein requirements in patients during the first week after onset of critical illness, without risk of overfeeding with energy.
- Conditions
- Critical Illness
- Being tested
- SmofKabiven® extra Nitrogen, Olimel N9E
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmofKabiven® extra NitrogenDrug
SmofKabiven® extra Nitrogen (Fresenius Kabi) is a sterile, hypertonic emulsion for parenteral nutrition, in a 3-chamber bag containing amino acids, glucose, a lipid emulsion, and electrolytes.
Olimel N9EDrug
Olimel N9E (Baxter) is a sterile, hypertonic emulsion for parenteral nutrition, in a 3-chamber bag containing amino acids, glucose, a lipid emulsion, and electrolytes.
| Study group | Role | What they receive |
|---|---|---|
| SmofKabiven® extra Nitrogen | Experimental | Parenteral nutrition with SmofKabiven® extra Nitrogen in a dosage to provide 10 kcal/kg/day on Study Day 2 and 20 kcal/kg/day on Study Days 3 through 6. Receives: Drug: SmofKabiven® extra Nitrogen |
| Olimel N9E | Active comparator | Parenteral nutrition with Olimel N9E in a dosage to provide 10 kcal/kg/day on Study Day 2 and 20 kcal/kg/day on Study Days 3 through 6. Receives: Drug: Olimel N9E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients reaching ≥70% of the cumulative target for protein delivery from Study Day 2 through Study Day 6
The cumulative target for protein delivery is 6.75 g/kg over 5 Study Days (based on a daily target of 0.75 g/kg/day on Study Day 2 and 1.5 g/kg/day on Study Days 3 through 6); 70% of the cumulative target for protein delivery is 4.73 g/kg.
The cumulative protein delivery is calculated as the cumulative intake of amino acids from study drug and protein from enteral or oral nutrition on Study Day 2 through Study Day 6.
Measured: 5 days
Secondary outcomes (3)
Percentage of the cumulative target for protein delivery reached from Study Day 2 through Study Day 6
Actual cumulative protein delivery (g/kg/5d) divided by 6.75 (g/kg/5d) and multiplied by 100.
Measured: 5 days
Mean cumulative protein delivery by parenteral, enteral, and oral nutrition from Study Day 2 through Study Day 6
Measured: 5 days
Calculated mean cumulative protein deficit during the period from Study Day 2 through Study Day 6
The cumulative protein deficit is calculated as the cumulative target for protein delivery (6.75 g/kg/5d) minus the actual administered dose (g/kg/5d amino acids from study drug + g/kg/5d from enteral and oral nutrition.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start26 Nov 2019
- Primary completion24 Mar 2020
- Study completion24 Mar 2020
Why it stopped: Study had to be put on hold after the outbreak of Covid-19 in the participating countries and was terminated in September 2020 since a date for re-starting was not foreseeable.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julien Bohe, Prof. MD, Principal investigator, Département d'Anesthésie-Réanimation, Centre Hospitalier Lyon Sud, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03992716
- Sponsor's protocol ID
- SKNt-001-CP4
- Other IDs
- 2017-001972-46, 2017
- Status last verified
- Oct 2020
- First submitted
- 13 Jun 2019
- Last updated
- 14 Oct 2020
- 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 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reaching Protein Target With SmofKabiven® Extra Nitrogen Versus Olimel N9E: A Prospective, Randomised, Active-controlled, Patient-blinded, Multicentre Clinical Trial During the Early Phase of Acute Critical Illness
- ClinicalTrials.gov ID
- NCT03992716
- Acronym / sponsor ID
- SKNt-001-CP4
- Conditions
- Critical Illness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study had to be put on hold after the outbreak of Covid-19 in the participating countries and was terminated in September 2020 since a date for re-starting was not foreseeable.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Fresenius KabiIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- 24 Mar 2020 (actual)
- Study completion
- 24 Mar 2020 (actual)
- First posted
- 20 Jun 2019 (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 main focus of the study is to show that SmofKabiven® extra Nitrogen, in a realistic clinical setting, enables to meet high protein requirements in patients during the first week after onset of critical illness, without risk of overfeeding with energy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SmofKabiven® extra Nitrogen | Experimental | Drug: SmofKabiven® extra NitrogenParenteral nutrition with SmofKabiven® extra Nitrogen in a dosage to provide 10 kcal/kg/day on Study Day 2 and 20 kcal/kg/day on Study Days 3 through 6. |
| Olimel N9E | Active comparator | Drug: Olimel N9EParenteral nutrition with Olimel N9E in a dosage to provide 10 kcal/kg/day on Study Day 2 and 20 kcal/kg/day on Study Days 3 through 6. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years and <90 years, male and female
- Critically ill, medical or surgical ICU patient
- Admitted to the ICU on the same day or the day before with a minimum expected ICU stay of 3 days
- Central venous access available for continuous infusion of the study drugs
- Sequential Organ Failure Assessment (SOFA) score ≥2
Key exclusion criteria (26 listed)
- Contraindication against parenteral nutrition or inability to receive parenteral nutrition via central venous access
- Received parenteral nutrition within 7 days before randomisation
- It is planned that patient receives ≥20% of the total target caloric intake via enteral or oral nutrition and/or non-nutritional sources (glucose solution for drug dilution or lipids from propofol/clevidipine or citrate from continuous renal replacement therapy) during the first 3 nutritional treatment days
- Body mass index (BMI) <18.5 kg/m2 or >35 kg/m2
- Burn injury
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 |
|---|---|---|
| SmofKabiven® extra NitrogenSmofKabiven® extra Nitrogen (Fresenius Kabi) is a sterile, hypertonic emulsion for parenteral nutrition, in a 3-chamber bag containing amino acids, glucose, a lipid emulsion, and electrolytes. | Drug | SmofKabiven® extra Nitrogen |
| Olimel N9EOlimel N9E (Baxter) is a sterile, hypertonic emulsion for parenteral nutrition, in a 3-chamber bag containing amino acids, glucose, a lipid emulsion, and electrolytes. | Drug | Olimel N9E |
Primary outcome
Proportion of patients reaching ≥70% of the cumulative target for protein delivery from Study Day 2 through Study Day 6
Time frame: 5 days
The cumulative target for protein delivery is 6.75 g/kg over 5 Study Days (based on a daily target of 0.75 g/kg/day on Study Day 2 and 1.5 g/kg/day on Study Days 3 through 6); 70% of the cumulative target for protein delivery is 4.73 g/kg. The cumulative protein delivery is calculated as the cumulative intake of amino acids from study drug and protein from enteral or oral nutrition on Study Day 2 through Study Day 6.
3 secondary outcomes
Percentage of the cumulative target for protein delivery reached from Study Day 2 through Study Day 6
Time frame: 5 days
Mean cumulative protein delivery by parenteral, enteral, and oral nutrition from Study Day 2 through Study Day 6
Time frame: 5 days
Calculated mean cumulative protein deficit during the period from Study Day 2 through Study Day 6
Time frame: 5 days
Results and safety
The study was stopped early (reason given: Study had to be put on hold after the outbreak of Covid-19 in the participating countries and was terminated in September 2020 since a date for re-starting was not foreseeable.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- 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.
Julien Bohe, Prof. MD principal investigator
Département d'Anesthésie-Réanimation, Centre Hospitalier Lyon Sud, France
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SmofKabiven® extra Nitrogen and Olimel N9E in people with Critical Illness, run by Fresenius Kabi at 3 sites in 3 countries.
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 7 inclusion and 26 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: stopped early, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Germany, Poland. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study had to be put on hold after the outbreak of Covid-19 in the participating countries and was terminated in September 2020 since a date for re-starting was not foreseeable.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients reaching ≥70% of the cumulative target for protein delivery from Study Day 2 through Study Day 6 (time frame: 5 days). 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 14 Oct 2020; AzTrials last refreshed its copy on 1 Nov 2026.