Liver TransplantationNCT04572373
Supplements SMOF in TPN for Liver Transplantation Recipients
An observational study of Liver Transplantation and Total Parenteral Nutrition, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Liver transplantation (LT) is one of the widely recognised and leading treatments for end-stage liver disease. Nutrition impacts its success. Total parenteral nutrition (TPN) is usually prescribed for patients recommended prolonged fasting after LT. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Transplantation, Total Parenteral Nutrition, End-stage Liver Disease
- What is being tested?
- SMOFlipid
- Type of treatment
- Pill or oral medicine
- How many people
- 54 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2012to 30 Jun 2015
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who underwent LT at KCGMH between Jan 2012 and June 2015 were screened in this study. The medical records of patients were retrospectively reviewed to check if TPN was provided in the last 14 days in the peri-transplantation period. TPN and SMOFlipid support were indicated for patients who received NPO for more than 3 days, such as those with repeated laparotomy, staged biliary reconstruction, massive nasogastric (NG) drainage (>500 mL/day), ileus, diarrhoea, poor digestion (NG extraction >50 mL/time), and chylous ascites.
Who may be able to join
- Adult (age > 18 years) LT recipients were enrolled
Who cannot join
- Renal dysfunction (eGFR < 60 mL/min/1.73 m2)
- Patients with well-tolerated oral intake and those in whom the TPN supplement was discontinued within 10 days were excluded from this study.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Chang Gung Memorial Hospital
Kaohsiung City, Niaosong District, 833
About this study
Liver transplantation (LT) is one of the widely recognised and leading treatments for end-stage liver disease. Nutrition impacts its success. Total parenteral nutrition (TPN) is usually prescribed for patients recommended prolonged fasting after LT. The supplement of SMOFlipid (soybean oil, MCT oil, olive oil, and fish oil) is easily metabolised to produce energy, and it possesses anti-inflammatory effects; however, SMOFlipid emulsion use raises concerns regarding coagulopathy after LT. This study investigated the postoperative correlation between SMOFlipid and coagulation in LT.
Read the detailed description
Liver failure is characterised by the loss of liver function and is complicated with hepatic encephalopathy and coagulopathy. Liver transplantation (LT) is one of the widely recognised and leading treatments for end-stage liver disease. Malnutrition is one of the common manifestations of this critical condition and is also an independent predictor of mortality. Several studies have shown that malnutrition is a poor prognostic factor for LT, which indicates that nutritional support may reduce LT complications and improve survival.
Total parenteral nutrition (TPN) is usually prescribed for patients recommended prolonged fasting after LT. The supplement of SMOFlipid (soybean oil, MCT oil, olive oil, and fish oil) has the advantage of being easily metabolised to produce energy, and it has anti-inflammatory effects. The major therapeutic mechanism of fish oil is the attenuation of systematic inflammation, which may decrease the mortality risk in patients with severe injury and sepsis. SMOFlipid has been proven to be safe and well tolerated in a wide range of clinical conditions, and it is used as the standard lipid emulsion. Moreover, the short-term application of parenteral fish oil with soybean oil not only significantly reduces the parameters of liver damage in the postoperative period but also leads to a more balanced immune response, which may result in the faster resolution of inflammation and recovery. However, SMOFlipid emulsion use may be associated with coagulopathy after LT. Early studies have shown that the dietary intake of n-3 fatty acids, which is a component of fat, is associated with antithrombotic effects but increases the risk of bleeding. A detailed analysis is lacking, and these observations have yet to be proven; this concern persists. Hence, the investigators should pay attention to the bleeding tendency when using fish oil fat emulsion because it may aggravate the risk of bleeding. Therefore, the use of fish oil-containing fat emulsion and its related risks is a clinically important issue in early LT that should be investigated, because liver function is not restored immediately after transplantation, and there is a tendency of coagulopathy. Thus, classical haemostasis parameters such as activated partial thromboplastin time (aPTT) and platelet count are measured prior to surgery and before the start of TPN. However, many questions remain unanswered regarding nutritional assessment and support for these seriously ill, nutritionally, and metabolically complex patients. This study evaluated the effect of the SMOFlipid supplement in TPN in LT patients.
- Being tested
- SMOFlipid
- Keywords
- Liver transplantation, SMOFlipid, fish oil
- Medical subject headings
- Hyperphagia, End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMOFlipidDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| SMOFlipid group | TPN and SMOFlipid support were indicated for patients who received NPO for more than 3 days, such as those with repeated laparotomy, staged biliary reconstruction, massive nasogastric (NG) drainage (>500 mL/day), ileus, diarrhoea, poor digestion (NG extraction >50 mL/time), and chylous ascites.
Furthermore, SMOFlipid was discontinued when the platelet count decreased to 40,000/μL or less. In all cases, heparinisation was prescribed to maintain the aPTT level between 1.5 and 2 times the normal controlled level at least for 10-14 days, with daily blood examination conducted. Oral administration of dipyridamole (75 mg, QID) for 3 months was indicated for stimulation of antiplatelet activity when the platelet count increased to 40,000/μL or more. Receives: Dietary Supplement: SMOFlipid | |
| non SMOFlipid group | On the basis of our experience in patient management at this institute, we allocated patients with a pretransplant platelet count less than 40,000/μL and those with a count more than 40,000/μL to the non-SMOFlipid group and the SMOFlipid group , respectively. Patients with well-tolerated oral intake and those in whom the TPN supplement was discontinued within 10 days were excluded from this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient demographics and clinical characteristics of SMOFlipid and non-SMOFlipid groups
Medical records including patient demographics, preoperative history, physical examination, clinical course, laboratory studies, aetiology of liver disease, severity of liver disease including Child-Pugh score and the Model for End-Stage Liver Disease (MELD) score, postoperative complications, and length of ICU and hospital stay were collected and reviewed.
Measured: 30 days
Coagulopathy profile and nutrition profile in SMOF group and non-SMOFlipid groups
Medical records including laboratory studies (PT (sec), INR (sec), aPTT (sec), Platelet (103/uL), Albumin (g/dL), Cholesterol (mg/dL), Triglyceride (mg/dL))
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start1 Jan 2012
- Primary completion30 Jun 2015
- Study completion30 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chih-Che Lin, MD, Study director, Department of Surgery, Kaohsiung Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572373
- Sponsor's protocol ID
- 201601322A3
- Status last verified
- Sep 2020
- First submitted
- 14 Sep 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Koffron A, Stein JA. Liver transplantation: indications, pretransplant evaluation, surgery, and posttransplant complications. Med Clin North Am. 2008 Jul;92(4):861-88, ix. doi: 10.1016/j.mcna.2008.03.008.
PubMed 18570946Merli M, Giusto M, Giannelli V, Lucidi C, Riggio O. Nutritional status and liver transplantation. J Clin Exp Hepatol. 2011 Dec;1(3):190-8. doi: 10.1016/S0973-6883(11)60237-5. Epub 2012 Jan 2.
PubMed 25755385Xu J, Yunshi Z, Li R. Immunonutrition in surgical patients. Curr Drug Targets. 2009 Aug;10(8):771-7. doi: 10.2174/138945009788982432.
PubMed 19702523Kerwin AJ, Nussbaum MS. Adjuvant nutrition management of patients with liver failure, including transplant. Surg Clin North Am. 2011 Jun;91(3):565-78. doi: 10.1016/j.suc.2011.02.010. Epub 2011 Apr 29.
PubMed 21621696Henkel AS, Buchman AL. Nutritional support in patients with chronic liver disease. Nat Clin Pract Gastroenterol Hepatol. 2006 Apr;3(4):202-9. doi: 10.1038/ncpgasthep0443.
PubMed 16582962Wei C, Hua J, Bin C, Klassen K. Impact of lipid emulsion containing fish oil on outcomes of surgical patients: systematic review of randomized controlled trials from Europe and Asia. Nutrition. 2010 May;26(5):474-81. doi: 10.1016/j.nut.2009.09.011. Epub 2010 Jan 29.
PubMed 20116213Manzanares W, Langlois PL, Dhaliwal R, Lemieux M, Heyland DK. Intravenous fish oil lipid emulsions in critically ill patients: an updated systematic review and meta-analysis. Crit Care. 2015 Apr 16;19(1):167. doi: 10.1186/s13054-015-0888-7.
PubMed 25879776Klek S, Chambrier C, Singer P, Rubin M, Bowling T, Staun M, Joly F, Rasmussen H, Strauss BJ, Wanten G, Smith R, Abraham A, Szczepanek K, Shaffer J. Four-week parenteral nutrition using a third generation lipid emulsion (SMOFlipid)--a double-blind, randomised, multicentre study in adults. Clin Nutr. 2013 Apr;32(2):224-31. doi: 10.1016/j.clnu.2012.06.011. Epub 2012 Jul 12.
PubMed 22796064Nandivada P, Fell GL, Gura KM, Puder M. Lipid emulsions in the treatment and prevention of parenteral nutrition-associated liver disease in infants and children. Am J Clin Nutr. 2016 Feb;103(2):629S-34S. doi: 10.3945/ajcn.114.103986. Epub 2016 Jan 20.
PubMed 26791189Zhu XH, Wu YF, Qiu YD, Jiang CP, Ding YT. Liver-protecting effects of omega-3 fish oil lipid emulsion in liver transplantation. World J Gastroenterol. 2012 Nov 14;18(42):6141-7. doi: 10.3748/wjg.v18.i42.6141.
PubMed 23155344Hammad A, Kaido T, Aliyev V, Mandato C, Uemoto S. Nutritional Therapy in Liver Transplantation. Nutrients. 2017 Oct 16;9(10):1126. doi: 10.3390/nu9101126.
PubMed 29035319Knapp HR. Dietary fatty acids in human thrombosis and hemostasis. Am J Clin Nutr. 1997 May;65(5 Suppl):1687S-1698S. doi: 10.1093/ajcn/65.5.1687S.
PubMed 9129511Heller AR, Fischer S, Rossel T, Geiger S, Siegert G, Ragaller M, Zimmermann T, Koch T. Impact of n-3 fatty acid supplemented parenteral nutrition on haemostasis patterns after major abdominal surgery. Br J Nutr. 2002 Jan;87 Suppl 1:S95-101. doi: 10.1079/bjn2001462.
PubMed 11895160Mateu de Antonio J, Florit-Sureda M. Effects unrelated to anti-inflammation of lipid emulsions containing fish oil in parenteral nutrition for adult patients. Nutr Hosp. 2017 Feb 1;34(1):193-203. doi: 10.20960/nh.882.
PubMed 28244792Starzl TE, Iwatsuki S, Esquivel CO, Todo S, Kam I, Lynch S, Gordon RD, Shaw BW Jr. Refinements in the surgical technique of liver transplantation. Semin Liver Dis. 1985 Nov;5(4):349-56. doi: 10.1055/s-2008-1040632. No abstract available.
PubMed 3909429
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplements SMOF in TPN for Liver Transplantation Recipients
- ClinicalTrials.gov ID
- NCT04572373
- Acronym / sponsor ID
- 201601322A3
- Keywords
- Liver transplantation, SMOFlipid, fish oil
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 1 Oct 2020 (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.
Liver transplantation (LT) is one of the widely recognised and leading treatments for end-stage liver disease. Nutrition impacts its success. Total parenteral nutrition (TPN) is usually prescribed for patients recommended prolonged fasting after LT. The supplement of SMOFlipid (soybean oil, MCT oil, olive oil, and fish oil) is easily metabolised to produce energy, and it possesses anti-inflammatory effects; however, SMOFlipid emulsion use raises concerns regarding coagulopathy after LT. This study investigated the postoperative correlation between SMOFlipid and coagulation in LT.
Detailed description
Liver failure is characterised by the loss of liver function and is complicated with hepatic encephalopathy and coagulopathy. Liver transplantation (LT) is one of the widely recognised and leading treatments for end-stage liver disease. Malnutrition is one of the common manifestations of this critical condition and is also an independent predictor of mortality. Several studies have shown that malnutrition is a poor prognostic factor for LT, which indicates that nutritional support may reduce LT complications and improve survival.
Total parenteral nutrition (TPN) is usually prescribed for patients recommended prolonged fasting after LT. The supplement of SMOFlipid (soybean oil, MCT oil, olive oil, and fish oil) has the advantage of being easily metabolised to produce energy, and it has anti-inflammatory effects. The major therapeutic mechanism of fish oil is the attenuation of systematic inflammation, which may decrease the mortality risk in patients with severe injury and sepsis. SMOFlipid has been proven to be safe and well tolerated in a wide range of clinical conditions, and it is used as the standard lipid emulsion. Moreover, the short-term application of parenteral fish oil with soybean oil not only significantly reduces the parameters of liver damage in the postoperative period but also leads to a more balanced immune response, which may result in the faster resolution of inflammation and recovery. However, SMOFlipid emulsion use may be associated with coagulopathy after LT. Early studies have shown that the dietary intake of n-3 fatty acids, which is a component of fat, is associated with antithrombotic effects but increases the risk of bleeding. A detailed analysis is lacking, and these observations have yet to be proven; this concern persists. Hence, the investigators should pay attention to the bleeding tendency when using fish oil fat emulsion because it may aggravate the risk of bleeding. Therefore, the use of fish oil-containing fat emulsion and its related risks is a clinically important issue in early LT that should be investigated, because liver function is not restored immediately after transplantation, and there is a tendency of coagulopathy. Thus, classical haemostasis parameters such as activated partial thromboplastin time (aPTT) and platelet count are measured prior to surgery and before the start of TPN. However, many questions remain unanswered regarding nutritional assessment and support for these seriously ill, nutritionally, and metabolically complex patients. This study evaluated the effect of the SMOFlipid supplement in TPN in LT patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMOFlipid group | – | Dietary Supplement: SMOFlipidTPN and SMOFlipid support were indicated for patients who received NPO for more than 3 days, such as those with repeated laparotomy, staged biliary reconstruction, massive nasogastric (NG) drainage (>500 mL/day), ileus, diarrhoea, poor digestion (NG extraction >50 mL/time), and chylous ascites. Furthermore, SMOFlipid was discontinued when the platelet count decreased to 40,000/μL or less. In all cases, heparinisation was prescribed to maintain the aPTT level between 1.5 and 2 times the normal controlled level at least for 10-14 days, with daily blood examination conducted. Oral administration of dipyridamole (75 mg, QID) for 3 months was indicated for stimulation of antiplatelet activity when the platelet count increased to 40,000/μL or more. |
| non SMOFlipid group | – | –On the basis of our experience in patient management at this institute, we allocated patients with a pretransplant platelet count less than 40,000/μL and those with a count more than 40,000/μL to the non-SMOFlipid group and the SMOFlipid group , respectively. Patients with well-tolerated oral intake and those in whom the TPN supplement was discontinued within 10 days were excluded from this study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who underwent LT at KCGMH between Jan 2012 and June 2015 were screened in this study. The medical records of patients were retrospectively reviewed to check if TPN was provided in the last 14 days in the peri-transplantation period. TPN and SMOFlipid support were indicated for patients who received NPO for more than 3 days, such as those with repeated laparotomy, staged biliary reconstruction, massive nasogastric (NG) drainage (>500 mL/day), ileus, diarrhoea, poor digestion (NG extraction >50 mL/time), and chylous ascites.
Key inclusion criteria (1 listed)
- Adult (age > 18 years) LT recipients were enrolled
Key exclusion criteria (2 listed)
- Renal dysfunction (eGFR < 60 mL/min/1.73 m2)
- Patients with well-tolerated oral intake and those in whom the TPN supplement was discontinued within 10 days were excluded from this study.
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 |
|---|---|---|
| SMOFlipid | Dietary supplement | SMOFlipid group |
Primary outcome
Patient demographics and clinical characteristics of SMOFlipid and non-SMOFlipid groups
Time frame: 30 days
Medical records including patient demographics, preoperative history, physical examination, clinical course, laboratory studies, aetiology of liver disease, severity of liver disease including Child-Pugh score and the Model for End-Stage Liver Disease (MELD) score, postoperative complications, and length of ICU and hospital stay were collected and reviewed.
Coagulopathy profile and nutrition profile in SMOF group and non-SMOFlipid groups
Time frame: 30 days
Medical records including laboratory studies (PT (sec), INR (sec), aPTT (sec), Platelet (103/uL), Albumin (g/dL), Cholesterol (mg/dL), Triglyceride (mg/dL))
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 8 Oct 2020.
- Results publication: PubMed 18570946Koffron A, Stein JA. Liver transplantation: indications, pretransplant evaluation, surgery, and posttransplant complications. Med Clin North Am. 2008 Jul;92(4):861-88, ix. doi: 10.1016/j.mcna.2008.03.008.
- Results publication: PubMed 25755385Merli M, Giusto M, Giannelli V, Lucidi C, Riggio O. Nutritional status and liver transplantation. J Clin Exp Hepatol. 2011 Dec;1(3):190-8. doi: 10.1016/S0973-6883(11)60237-5. Epub 2012 Jan 2.
- Results publication: PubMed 19702523Xu J, Yunshi Z, Li R. Immunonutrition in surgical patients. Curr Drug Targets. 2009 Aug;10(8):771-7. doi: 10.2174/138945009788982432.
- Results publication: PubMed 21621696Kerwin AJ, Nussbaum MS. Adjuvant nutrition management of patients with liver failure, including transplant. Surg Clin North Am. 2011 Jun;91(3):565-78. doi: 10.1016/j.suc.2011.02.010. Epub 2011 Apr 29.
- Results publication: PubMed 16582962Henkel AS, Buchman AL. Nutritional support in patients with chronic liver disease. Nat Clin Pract Gastroenterol Hepatol. 2006 Apr;3(4):202-9. doi: 10.1038/ncpgasthep0443.
- Results publication: PubMed 20116213Wei C, Hua J, Bin C, Klassen K. Impact of lipid emulsion containing fish oil on outcomes of surgical patients: systematic review of randomized controlled trials from Europe and Asia. Nutrition. 2010 May;26(5):474-81. doi: 10.1016/j.nut.2009.09.011. Epub 2010 Jan 29.
- Results publication: PubMed 25879776Manzanares W, Langlois PL, Dhaliwal R, Lemieux M, Heyland DK. Intravenous fish oil lipid emulsions in critically ill patients: an updated systematic review and meta-analysis. Crit Care. 2015 Apr 16;19(1):167. doi: 10.1186/s13054-015-0888-7.
- Results publication: PubMed 22796064Klek S, Chambrier C, Singer P, Rubin M, Bowling T, Staun M, Joly F, Rasmussen H, Strauss BJ, Wanten G, Smith R, Abraham A, Szczepanek K, Shaffer J. Four-week parenteral nutrition using a third generation lipid emulsion (SMOFlipid)--a double-blind, randomised, multicentre study in adults. Clin Nutr. 2013 Apr;32(2):224-31. doi: 10.1016/j.clnu.2012.06.011. Epub 2012 Jul 12.
- Results publication: PubMed 26791189Nandivada P, Fell GL, Gura KM, Puder M. Lipid emulsions in the treatment and prevention of parenteral nutrition-associated liver disease in infants and children. Am J Clin Nutr. 2016 Feb;103(2):629S-34S. doi: 10.3945/ajcn.114.103986. Epub 2016 Jan 20.
- Results publication: PubMed 23155344Zhu XH, Wu YF, Qiu YD, Jiang CP, Ding YT. Liver-protecting effects of omega-3 fish oil lipid emulsion in liver transplantation. World J Gastroenterol. 2012 Nov 14;18(42):6141-7. doi: 10.3748/wjg.v18.i42.6141.
- Results publication: PubMed 29035319Hammad A, Kaido T, Aliyev V, Mandato C, Uemoto S. Nutritional Therapy in Liver Transplantation. Nutrients. 2017 Oct 16;9(10):1126. doi: 10.3390/nu9101126.
- Results publication: PubMed 9129511Knapp HR. Dietary fatty acids in human thrombosis and hemostasis. Am J Clin Nutr. 1997 May;65(5 Suppl):1687S-1698S. doi: 10.1093/ajcn/65.5.1687S.
- Individual participant dataSharing planned: Undecided
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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.
Chih-Che Lin, MD study director
Department of Surgery, Kaohsiung Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation and Total Parenteral Nutrition, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 2 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 8 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 1 site in Taiwan. 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.
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?
Patient demographics and clinical characteristics of SMOFlipid and non-SMOFlipid groups (time frame: 30 days). The study lists 2 primary outcomes in all. 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 NCT04572373, which also lists 23 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 8 Oct 2020.