Parenteral NutritionPhase 3NCT03792100

Efficacy & Safety of SmofKabiven Emulsion for Infusion vs Hospital Compounded "All in One" for Parenteral Nutrition

A Phase 3 study testing SmofKabiven emulsion for infusion and Hospital compounded "All in one" emulsion in people with Parenteral Nutrition and Surgery, run by Fresenius Kabi at 8 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The present protocol describes a randomized, patient-blinded study in which either SmofKabiven emulsion for infusion or a hospital compounded "All in one" control Total Parenteral Nutrition (TPN) regimen will be given to adult surgical patients for 5 consecutive days. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Parenteral Nutrition, Surgery
What is being tested?: SmofKabiven emulsion for infusion and Hospital compounded "All in one" emulsion
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 273 participants
Where: 8 sitesChina
Study dates: 3 Jan 2019to 23 Jan 2020
Phase: Phase 3
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient is scheduled to undergo elective gastrointestinal surgery;
Female or male patients, age ≥ 18 and ≤ 80 years;
Postoperatively, patient is expected to receive 100% of the total daily energy demand via PN for at least 5 consecutive days;
Body Mass Index (BMI) ≥ 16 kg/m2 and ≤ 30 kg /m2, and actual body weight ≥ 40 kg;
Patient is capable to give Informed Consent, agrees to participate in the study, and signs the Informed Consent Form.

Who cannot join

Patient has received PN or parenteral amino acids in the last 10 days before randomization (exception: administration of glucose will be allowed);
Known severe liver insufficiency in the medical history, or AST or ALT at least 3.0-times higher than the upper limit of normal range or total bilirubin at least 1.5-times higher than the upper limit of normal range;
International Normalised Ratio (INR) at least 1.5 times higher than the upper limit of normal range;
Uncontrolled hyperglycaemia defined as fasting blood glucose > 180 mg/ dl (10 mmol/L);
Severe renal impairment defined as serum creatinine value at least 1.5 times higher than the upper limit of normal range;
Serious hyperlipidaemia (serum cholesterol and/or triglycerides and/or LDL-C level at least 1.5 times higher than the upper limit of normal range);

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Known inborn abnormality of amino acid metabolism in the medical history;
Known acute pancreatitis in the medical history;
Known hypothyroidism or hyperthyroidism in the medical history;
Serum level of any of the electrolytes (sodium, potassium, magnesium, total calcium, chloride, phosphate) above the upper limit of the normal range;
Known unstable metabolism in the medical history (e.g., metabolic acidosis);
Known hypersensitivity to fish, egg, soybean, or peanut protein or to any of the active substances or excipients of the study drugs in the medical history;
General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, and decompensated cardiac insufficiency /congestive heart failure;
Unstable haemodynamic conditions (e.g., acute myocardial infarction, stroke, embolism, severe sepsis, shock);
Known hemophagocytic syndrome;
Patients diagnosed with an infection before the surgery;
Drug abuse and/or chronic alcoholism;
Psychiatric diseases, epilepsy;
Administration of growth hormones within the previous 4 weeks before surgery, or chronic maintenance therapy with systemic glucocorticoids 4 weeks before surgery;
Participation in a clinical study with an investigational drug or an investigational medical device within one month prior to start of study or during study;
Patient is pregnant or lactating and intends to continue breast-feeding;
Development of intraoperative/ postoperative conditions (assessed after surgery and before enrolment of patients):
Intra-operative blood loss > 1000 ml;
Development of a condition in which PN is contraindicated;
Intra- or postoperative urine output < 0.5 ml/kg/h;
Need for postoperative haemofiltration or dialysis;
Contraindication or inability to obtain central venous catheter access;
Intra-operative decision on limited treatment, e.g. due to diagnosis of carcinomatosis;
Intra-operative severe complications including resuscitation, hemorrhagic and septic shock, acute single and multiple organ dysfunction including pulmonary, hepatic, and renal dysfunction prohibiting early postsurgical extubation, requiring liver-specific treatment and renal replacement therapy.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

China8 sites

Beijing Friendship Hospital, Capital Medical University
Beijing
The Second Hospital of Jilin University
Changchun
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou
Thepeople's hospital of Guangxi zhuang
Nanning
Shanghai First People's hospital
Shanghai
Shanghai Pudong Hospital
Shanghai
Zhongshan Hospital Fudan University
Shanghai
Shanxi Provincial People's Hospital
Taiyuan

Other trials in China

About this study

Official title: Efficacy & Safety of SmofKabiven Emulsion for Infusion vs Hospital Compounded "All in One" for Parenteral Nutrition (PN): A Randomized, Active-Controlled, Patient-blinded, Multi-Centre Study in Adult Surgical Patients Requiring PN

As serum prealbumin is a well-established surrogate efficacy parameter reflecting the patient´s nutritional status, the change of the serum prealbumin level at the day of the final study visit compared to baseline will represent the primary efficacy parameter in the present study.

Read the detailed description

In addition, other variables will be assessed in this study, i.e., postsurgical new onset of nosocomial infection, CRP, free fatty acids, immunology parameters, the results of physical examination, vital signs, relevant nutrition- and safety-related laboratory parameters in venous blood and urine, the results of an Electrocardiography (ECG), and the number, severity, seriousness, clinical relevance, relatedness and outcome of Adverse Events (AEs). The aim of the planned study is to demonstrate that SmofKabiven emulsion for infusion is not inferior to the comparative drug (hospital compounded "All in one" emulsion for parenteral nutrition).

Conditions: Parenteral Nutrition, Surgery
Being tested: SmofKabiven emulsion for infusion, Hospital compounded "All in one" emulsion
Keywords: SmofKabiven, Abdominal surgery, Parenteral, Nutrition
Medical subject headings: Hyperphagia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SmofKabiven emulsion for infusionDrug
Also called Study intervention, Investigational Product
Total Parenteral Nutrition
Hospital compounded "All in one" emulsionDrug
Also called Control, Comparator
Total Parenteral Nutrition

Study groups in NCT03792100
Study group	Role	What they receive
SmofKabiven emulsion for infusion	Experimental	SmofKabiven emulsion for infusion will be continuously infused intravenously via central venous access for approximately 14-24 h/d. Duration of treatment with the study drug is 5 consecutive days.Targeted daily dose is 26.3 ml/kg bw/day resulting in 29.3 kcal/kg bw/day. Dosage on D 1 will be reduced to 50%. Receives: Drug: SmofKabiven emulsion for infusion
Hospital compounded "All in one" emulsion for PN	Active comparator	Hospital compounded "All in one" emulsion will be continuously infused intravenously via central venous access for approximately 14-24 h/d. Duration of treatment with the study drugs will be 5 consecutive days.Targeted daily dose is 26.3 ml/kg bw/day resulting in 29.3 kcal/kg bw/day. Dosage on D 1 will be reduced to 50%. Receives: Drug: Hospital compounded "All in one" emulsion

What is being measured

The primary outcome is the main question the study is designed to answer.

Serum Prealbumin
Change in Serum Prealbumin
Measured: 6 days

Secondary outcomes (14)

Nosocomial infection
Postsurgical new onset of nosocomial infection
Measured: 6 days
Prealbumin
Change in Prealbumin
Measured: 4 days
C-reactive Protein (CRP)
Change in CRP
Measured: 6 days
Linoleic acid
Change in linoleic acid
Measured: 6 days
Linolenic acid
Change in linolenic acid
Measured: 6 days
Arachidonic acid
Change in arachidonic acid
Measured: 6 days
Eicosapentaenoic acid (EPA)
Change in EPA
Measured: 6 days
Docosahexaenoic acis (DHA)
Change in DHA
Measured: 6 days
Thromboxane B3 (TX B3) / Thromboxane B2 (TX B2)
Change in TX B3/B2
Measured: 6 days
Interleukin (IL)-1
Change in IL-1
Measured: 6 days
Interleukin (IL)-2
Change in IL-2
Measured: 6 days
Interleukin (IL)-6
Change in IL-6
Measured: 6 days
Cluster of Differentiation 4 (CD4) / Cluster of Differentiation 8 (CD8)
Change in CD4/CD8
Measured: 6 days
Plasma amino acid (taurine)
Change in taurine
Measured: 6 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jan 201923 Jan 2020

First posted3 Jan 2019
Study start3 Jan 2019
Primary completion23 Jan 2020
Study completion23 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (29)Papers the sponsor has linked to this study.
Other trials for Parenteral NutritionStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 273 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03792100
Sponsor's protocol ID: SMKV-015-CP3
Status last verified: Jul 2021
First submitted: 14 Nov 2018
Last updated: 2 Aug 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Calder PC. n-3 fatty acids, inflammation, and immunity--relevance to postsurgical and critically ill patients. Lipids. 2004 Dec;39(12):1147-61. doi: 10.1007/s11745-004-1342-z.
PubMed 15736910
Mayer K, Gokorsch S, Fegbeutel C, Hattar K, Rosseau S, Walmrath D, Seeger W, Grimminger F. Parenteral nutrition with fish oil modulates cytokine response in patients with sepsis. Am J Respir Crit Care Med. 2003 May 15;167(10):1321-8. doi: 10.1164/rccm.200207-674OC. Epub 2003 Feb 25.
PubMed 12615625
Novak TE, Babcock TA, Jho DH, Helton WS, Espat NJ. NF-kappa B inhibition by omega -3 fatty acids modulates LPS-stimulated macrophage TNF-alpha transcription. Am J Physiol Lung Cell Mol Physiol. 2003 Jan;284(1):L84-9. doi: 10.1152/ajplung.00077.2002. Epub 2002 Aug 30.
PubMed 12388359
Pluess TT, Hayoz D, Berger MM, Tappy L, Revelly JP, Michaeli B, Carpentier YA, Chiolero RL. Intravenous fish oil blunts the physiological response to endotoxin in healthy subjects. Intensive Care Med. 2007 May;33(5):789-797. doi: 10.1007/s00134-007-0591-5. Epub 2007 Mar 22.
PubMed 17377770
Xiong J, Zhu S, Zhou Y, Wu H, Wang C. Regulation of omega-3 fish oil emulsion on the SIRS during the initial stage of severe acute pancreatitis. J Huazhong Univ Sci Technolog Med Sci. 2009 Feb;29(1):35-8. doi: 10.1007/s11596-009-0107-3. Epub 2009 Feb 18.
PubMed 19224159
Helmut Grimm, A balanced lipid emulsion-A new concept in parenteral nutrition. Clinical Nutrition Supplements (2005) 1, 25-30.
Grimm H, Mertes N, Goeters C, Schlotzer E, Mayer K, Grimminger F, Furst P. Improved fatty acid and leukotriene pattern with a novel lipid emulsion in surgical patients. Eur J Nutr. 2006 Feb;45(1):55-60. doi: 10.1007/s00394-005-0573-8. Epub 2005 Jul 22.
PubMed 16041475
Puder M, Valim C, Meisel JA, Le HD, de Meijer VE, Robinson EM, Zhou J, Duggan C, Gura KM. Parenteral fish oil improves outcomes in patients with parenteral nutrition-associated liver injury. Ann Surg. 2009 Sep;250(3):395-402. doi: 10.1097/SLA.0b013e3181b36657.
PubMed 19661785
Gura KM, Duggan CP, Collier SB, Jennings RW, Folkman J, Bistrian BR, Puder M. Reversal of parenteral nutrition-associated liver disease in two infants with short bowel syndrome using parenteral fish oil: implications for future management. Pediatrics. 2006 Jul;118(1):e197-201. doi: 10.1542/peds.2005-2662.
PubMed 16818533
Alwayn IP, Gura K, Nose V, Zausche B, Javid P, Garza J, Verbesey J, Voss S, Ollero M, Andersson C, Bistrian B, Folkman J, Puder M. Omega-3 fatty acid supplementation prevents hepatic steatosis in a murine model of nonalcoholic fatty liver disease. Pediatr Res. 2005 Mar;57(3):445-52. doi: 10.1203/01.PDR.0000153672.43030.75. Epub 2005 Jan 19.
PubMed 15659701
Bouletreau P, Chassard D, Allaouchiche B, Dumont JC, Auboyer C, Bertin-Maghit M, Bricard H, Ecochard R, Rangaraj J, Chambrier C, Schneid C, Cynober L. Glucose-lipid ratio is a determinant of nitrogen balance during total parenteral nutrition in critically ill patients: a prospective, randomized, multicenter blind trial with an intention-to-treat analysis. Intensive Care Med. 2005 Oct;31(10):1394-400. doi: 10.1007/s00134-005-2771-5. Epub 2005 Aug 24.
PubMed 16132885
Sergi G, Coin A, Enzi G, Volpato S, Inelmen EM, Buttarello M, Peloso M, Mulone S, Marin S, Bonometto P. Role of visceral proteins in detecting malnutrition in the elderly. Eur J Clin Nutr. 2006 Feb;60(2):203-9. doi: 10.1038/sj.ejcn.1602289.
PubMed 16234837
Shenkin A. Serum prealbumin: Is it a marker of nutritional status or of risk of malnutrition? Clin Chem. 2006 Dec;52(12):2177-9. doi: 10.1373/clinchem.2006.077412. No abstract available.
PubMed 17138848
Young GA, Hill GL. Assessment of protein-calorie malnutrition in surgical patients from plasma proteins and anthropometric measurements. Am J Clin Nutr. 1978 Mar;31(3):429-35. doi: 10.1093/ajcn/31.3.429.
PubMed 415592
Young GA, Collins JP, Hill GL. Plasma proteins in patients receiving intravenous amino acids or intravenous hyperalimentation after major surgery. Am J Clin Nutr. 1979 Jun;32(6):1192-9. doi: 10.1093/ajcn/32.6.1192.
PubMed 87126

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy & Safety of SmofKabiven Emulsion for Infusion vs Hospital Compounded "All in One" for Parenteral Nutrition (PN): A Randomized, Active-Controlled, Patient-blinded, Multi-Centre Study in Adult Surgical Patients Requiring PN
ClinicalTrials.gov ID: NCT03792100
Acronym / sponsor ID: SMKV-015-CP3
Conditions: Parenteral Nutrition, Surgery
Keywords: SmofKabiven, Abdominal surgery, Parenteral, Nutrition
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 273 participants (actual)
Lead sponsor: Fresenius KabiIndustry (pharma, biotech, devices)
Collaborators: Parexel
Study start: 3 Jan 2019 (actual)
Primary completion: 23 Jan 2020 (actual)
Study completion: 23 Jan 2020 (actual)
First posted: 3 Jan 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
SmofKabiven emulsion for infusion	Experimental	Drug: SmofKabiven emulsion for infusionSmofKabiven emulsion for infusion will be continuously infused intravenously via central venous access for approximately 14-24 h/d. Duration of treatment with the study drug is 5 consecutive days.Targeted daily dose is 26.3 ml/kg bw/day resulting in 29.3 kcal/kg bw/day. Dosage on D 1 will be reduced to 50%.
Hospital compounded "All in one" emulsion for PN	Active comparator	Drug: Hospital compounded "All in one" emulsionHospital compounded "All in one" emulsion will be continuously infused intravenously via central venous access for approximately 14-24 h/d. Duration of treatment with the study drugs will be 5 consecutive days.Targeted daily dose is 26.3 ml/kg bw/day resulting in 29.3 kcal/kg bw/day. Dosage on D 1 will be reduced to 50%.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patient is scheduled to undergo elective gastrointestinal surgery;
Female or male patients, age ≥ 18 and ≤ 80 years;
Postoperatively, patient is expected to receive 100% of the total daily energy demand via PN for at least 5 consecutive days;
Body Mass Index (BMI) ≥ 16 kg/m2 and ≤ 30 kg /m2, and actual body weight ≥ 40 kg;
Patient is capable to give Informed Consent, agrees to participate in the study, and signs the Informed Consent Form.

Key exclusion criteria (29 listed)

Patient has received PN or parenteral amino acids in the last 10 days before randomization (exception: administration of glucose will be allowed);
Known severe liver insufficiency in the medical history, or AST or ALT at least 3.0-times higher than the upper limit of normal range or total bilirubin at least 1.5-times higher than the upper limit of normal range;
International Normalised Ratio (INR) at least 1.5 times higher than the upper limit of normal range;
Uncontrolled hyperglycaemia defined as fasting blood glucose > 180 mg/ dl (10 mmol/L);
Severe renal impairment defined as serum creatinine value at least 1.5 times higher than the upper limit of normal range;

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 emulsion for infusionAlso: Study intervention, Investigational ProductTotal Parenteral Nutrition	Drug	SmofKabiven emulsion for infusion
Hospital compounded "All in one" emulsionAlso: Control, ComparatorTotal Parenteral Nutrition	Drug	Hospital compounded "All in one" emulsion for PN

Primary outcome

Serum Prealbumin
Time frame: 6 days
Change in Serum Prealbumin

14 secondary outcomes

Nosocomial infection
Time frame: 6 days
Prealbumin
Time frame: 4 days
C-reactive Protein (CRP)
Time frame: 6 days
Linoleic acid
Time frame: 6 days
Linolenic acid
Time frame: 6 days
Arachidonic acid
Time frame: 6 days
Eicosapentaenoic acid (EPA)
Time frame: 6 days
Docosahexaenoic acis (DHA)
Time frame: 6 days
Thromboxane B3 (TX B3) / Thromboxane B2 (TX B2)
Time frame: 6 days
Interleukin (IL)-1
Time frame: 6 days
Interleukin (IL)-2
Time frame: 6 days
Interleukin (IL)-6
Time frame: 6 days
Cluster of Differentiation 4 (CD4) / Cluster of Differentiation 8 (CD8)
Time frame: 6 days
Plasma amino acid (taurine)
Time frame: 6 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
Background: PubMed 15736910Calder PC. n-3 fatty acids, inflammation, and immunity--relevance to postsurgical and critically ill patients. Lipids. 2004 Dec;39(12):1147-61. doi: 10.1007/s11745-004-1342-z.
Background: PubMed 12615625Mayer K, Gokorsch S, Fegbeutel C, Hattar K, Rosseau S, Walmrath D, Seeger W, Grimminger F. Parenteral nutrition with fish oil modulates cytokine response in patients with sepsis. Am J Respir Crit Care Med. 2003 May 15;167(10):1321-8. doi: 10.1164/rccm.200207-674OC. Epub 2003 Feb 25.
Background: PubMed 12388359Novak TE, Babcock TA, Jho DH, Helton WS, Espat NJ. NF-kappa B inhibition by omega -3 fatty acids modulates LPS-stimulated macrophage TNF-alpha transcription. Am J Physiol Lung Cell Mol Physiol. 2003 Jan;284(1):L84-9. doi: 10.1152/ajplung.00077.2002. Epub 2002 Aug 30.
Background: PubMed 17377770Pluess TT, Hayoz D, Berger MM, Tappy L, Revelly JP, Michaeli B, Carpentier YA, Chiolero RL. Intravenous fish oil blunts the physiological response to endotoxin in healthy subjects. Intensive Care Med. 2007 May;33(5):789-797. doi: 10.1007/s00134-007-0591-5. Epub 2007 Mar 22.
Background: PubMed 19224159Xiong J, Zhu S, Zhou Y, Wu H, Wang C. Regulation of omega-3 fish oil emulsion on the SIRS during the initial stage of severe acute pancreatitis. J Huazhong Univ Sci Technolog Med Sci. 2009 Feb;29(1):35-8. doi: 10.1007/s11596-009-0107-3. Epub 2009 Feb 18.
BackgroundHelmut Grimm, A balanced lipid emulsion-A new concept in parenteral nutrition. Clinical Nutrition Supplements (2005) 1, 25-30.
Background: PubMed 16041475Grimm H, Mertes N, Goeters C, Schlotzer E, Mayer K, Grimminger F, Furst P. Improved fatty acid and leukotriene pattern with a novel lipid emulsion in surgical patients. Eur J Nutr. 2006 Feb;45(1):55-60. doi: 10.1007/s00394-005-0573-8. Epub 2005 Jul 22.
Background: PubMed 19661785Puder M, Valim C, Meisel JA, Le HD, de Meijer VE, Robinson EM, Zhou J, Duggan C, Gura KM. Parenteral fish oil improves outcomes in patients with parenteral nutrition-associated liver injury. Ann Surg. 2009 Sep;250(3):395-402. doi: 10.1097/SLA.0b013e3181b36657.
Background: PubMed 16818533Gura KM, Duggan CP, Collier SB, Jennings RW, Folkman J, Bistrian BR, Puder M. Reversal of parenteral nutrition-associated liver disease in two infants with short bowel syndrome using parenteral fish oil: implications for future management. Pediatrics. 2006 Jul;118(1):e197-201. doi: 10.1542/peds.2005-2662.
Background: PubMed 15659701Alwayn IP, Gura K, Nose V, Zausche B, Javid P, Garza J, Verbesey J, Voss S, Ollero M, Andersson C, Bistrian B, Folkman J, Puder M. Omega-3 fatty acid supplementation prevents hepatic steatosis in a murine model of nonalcoholic fatty liver disease. Pediatr Res. 2005 Mar;57(3):445-52. doi: 10.1203/01.PDR.0000153672.43030.75. Epub 2005 Jan 19.
Background: PubMed 16132885Bouletreau P, Chassard D, Allaouchiche B, Dumont JC, Auboyer C, Bertin-Maghit M, Bricard H, Ecochard R, Rangaraj J, Chambrier C, Schneid C, Cynober L. Glucose-lipid ratio is a determinant of nitrogen balance during total parenteral nutrition in critically ill patients: a prospective, randomized, multicenter blind trial with an intention-to-treat analysis. Intensive Care Med. 2005 Oct;31(10):1394-400. doi: 10.1007/s00134-005-2771-5. Epub 2005 Aug 24.
Background: PubMed 16234837Sergi G, Coin A, Enzi G, Volpato S, Inelmen EM, Buttarello M, Peloso M, Mulone S, Marin S, Bonometto P. Role of visceral proteins in detecting malnutrition in the elderly. Eur J Clin Nutr. 2006 Feb;60(2):203-9. doi: 10.1038/sj.ejcn.1602289.
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.

Zhang Zhongtao, MD principal investigator

Beijing Friendship Hospital

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SmofKabiven emulsion for infusion and Hospital compounded "All in one" emulsion in people with Parenteral Nutrition and Surgery, run by Fresenius Kabi at 8 sites in China.

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 5 inclusion and 29 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: finished, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Serum Prealbumin (time frame: 6 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03792100, which also lists 29 linked publications.

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 2 Aug 2021.