14 completed, 7 terminated, 1 recruiting, 1 withdrawn. 23 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 23 | Completed 14, Terminated 7, Recruiting 1, Withdrawn 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients SMOFlipid® (lipid injectable emulsion) - Malnutrition, Child, Malnutrition | Phase 4 | Recruiting | Fresenius Kabi | 100 | 2024-10-28 | 2026-10-22 |
| Safety and Efficacy Study to Compare Smoflipid and Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age Smoflipid, Intralipid, 20% - Malnutrition, Child | Phase 4 | Terminated | Fresenius Kabi | 1 | 2019-12-18 | 2022-12-12 |
| Reaching Protein Target With SmofKabiven® Extra Nitrogen vs Olimel N9E During the Early Phase of Acute Critical Illness SmofKabiven® extra Nitrogen, Olimel N9E - Critical Illness | Phase 4 | Terminated | Fresenius Kabi | 7 | 2019-11-26 | 2020-10-14 |
| Safety and Efficacy of a 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Trauma Patients Volulyte 6%, Ionolyte - Hypovolemia Due to Acute Blood Loss | Phase 4 | Completed | Fresenius Kabi | 238 | 2019-02-23 | 2022-08-05 |
| MORphine Use in the Fascia Iliaca Compartment Block With UltraSound Levobupivacaine, Placebo, Acetaminophen - Humans, Anesthetics, Local | Phase 4 | Terminated | Zuyderland Medisch Centrum | 55 | 2019-01-28 | 2021-05-06 |
| Blood Glucose Response After Oral Intake of Lactulose in Mildly Constipated Patients With Diabetes Mellitus Type 2 Lactulose crystals 20 g, Lactulose crystals 30 g, Lactulose liquid 20 g - Diabetes Mellitus, Type 2 | Phase 4 | Completed | Fresenius Kabi | 24 | 2018-11-26 | 2019-04-12 |
| Study to Assess Safety and Efficacy of Kabiven® in Pediatric Patients 2 to 16 Years of Age Kabiven®, Compounded standard parenteral nutrition - Malnutrition | Phase 4 | Withdrawn | Fresenius Kabi | 2018-03-01 | 2019-09-04 | |
| Efficacy Study of Long-term Parenteral Nutrition With SmofKabiven® E in Lung Cancer Patients Under Anticancer Therapy SmofKabiven® E - Cancer-related Malnutrition | Phase 4 | Terminated | Fresenius Kabi | 2 | 2018-02-28 | 2019-05-01 |
| Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery Volulyte 6%, Ionolyte - Hypovolaemia Due to Acute Blood Loss | Phase 4 | Completed | Fresenius Kabi | 2289 | 2017-09-28 | 2024-01-31 |
| Early Goal-Directed Nutrition in ICU Patients - EAT-ICU Trial Early Goal-Directed Nutrition, ASPEN-guidelines - Critical Illness, Intensive Care (ICU) Myopathy | Phase 4 | Completed | Copenhagen University Hospital, Rigshospitalet | 203 | 2013-06-01 | 2017-01-05 |
| Fluid Resuscitation in Patients Suffering From Burns Injury Volulyte, Human Serum Albumin - Burns | Phase 4 | Terminated | Fresenius Kabi | 11 | 2012-12-01 | 2014-06-26 |
| VolulyteTM in Cardiac Surgery 6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM), Human serum albumin - Heart; Dysfunction Postoperative, Cardiac Surgery | Phase 4 | Completed | Fresenius Kabi | 133 | 2012-10-01 | 2014-06-26 |
| The Impact of Preoperative Oral Glutamine Intake on the Immunocompetence and Outcomes of Malnourished Patients Undergoing Major Abdominal Surgery Due to Malignancies Glutamine, Placebo - Malnourishment, Gastrointestinal Tumors | Phase 4 | Completed | Insel Gruppe AG, University Hospital Bern | 42 | 2012-05-01 | 2018-02-13 |
| Perioperative Colloid vs Crystalloid in Patients Undergoing Colorectal Surgery balanced 6% hydroxyethylstarch 130/0.4, balanced crystalloid - Surgery, Colorectal | Phase 4 | Terminated | University Hospital Muenster | 31 | 2011-04-01 | 2015-12-18 |
| Colloids in Severe Trauma tetrastarch (Voluven) - Abdominal Hypertension, Abdominal Compartment Syndrome | Phase 4 | Completed | University of the Philippines | 50 | 2009-05-01 | 2009-11-25 |
| Voluven® in Paediatric Patients HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L), Human serum albumin (HSA 50g/L) - Cardiac Surgery, Cardiopulmonary Bypass | Phase 4 | Completed | Fresenius Kabi | 61 | 2009-03-01 | 2011-11-02 |
| Efficacy of Voluven® for the Prevention of Hypotension During Spinal Anesthesia for Cesarean Section HES 130/0.4 (6%) in sodium chloride (solution for infusion), Ringer's Lactate solution - Hypotension | Phase 4 | Completed | Fresenius Kabi | 167 | 2008-06-01 | 2012-05-31 |
| Crystalloids Versus Colloids During Surgery Lactated Ringer's Solution, Hydroxyethylstarch 6% 130/0.4 - Fluid Overload, Postoperative Complications | Phase 4 | Completed | Medical University of Vienna | 1109 | 2006-09-01 | 2018-01-10 |
| Controlled Study to Evaluate Efficacy and Safety of α-KA Tab With Low Protein Diet (LPD) in Delaying the Progress of Type 2 Diabetic Nephropathy (DN) Ketosteril®, diabetic diet - Diabetic Nephropathy | Phase 4 | Completed | Fresenius Kabi | 179 | 2006-05-01 | 2010-09-02 |
| Hydroxyethyl Starch (130/0.4) for Intravascular Volume Therapy in Liver Transplantation Hydroxyethylstarch 130/0.4, 5% Albumin - Intraoperative Complications | Phase 4 | Terminated | Fresenius Kabi | 53 | 2005-10-01 | 2009-01-15 |
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Malnutrition (5) · Hyperphagia (3) · Child Nutrition Disorders (2) · Critical Illness (2) · Postoperative Complications (2) · Agnosia (1) · Brain Injuries, Traumatic (1) · Burns (1) · Coma (1) · Constipation (1) · Diabetes Mellitus, Type 2 (1) · Diabetic Nephropathies (1) · Digestive System Neoplasms (1) · Edema (1) · Emergencies (1)
Hydroxyethyl Starch Derivatives (9) · HES 130-0.4 (4) · Serum Albumin, Human (3) · Ringer's Lactate (2) · SMOFlipid (2) · Sodium Chloride (2) · Solutions (2) · Acetaminophen (1) · Albumins (1) · Diet, Diabetic (1) · Drug and Narcotic Control (1) · Drugs, Investigational (1) · Glucose (1) · Glutamine (1) · Levobupivacaine (1)
France (5) · Germany (5) · Austria (4) · Belgium (3) · China (3) · Netherlands (3) · United States (3) · Czechia (2) · Poland (2) · Spain (2) · Switzerland (2) · Canada (1) · Croatia (1) · Denmark (1) · Philippines (1)
Jeffrey Rudolph, MD (2) · Wolfgang F. Buhre, Prof. Dr. med. (2) · Anders Perner, Professor, MD, PhD (1) · David C Mazer (1) · Edith Fleischmann, M.D., Ph.D. (1) · Frederic Mercier, Professor (1) · Hans Gombotz, Professor (1) · Helmut Mann, Prof. Dr. (1) · Hugo Van Aken, Prof. MD (1) · Jean-Philippe Durand, MD (1) · Joel D Lim, MD (1) · John F Stover, MD (1) · Julien Bohe, Prof. MD (1) · Matilde Jo Allingstrup, PhD Fellow, MSc (1)
PMID 30017128, PMID 1015603, PMID 11331167, PMID 11331334, PMID 11374619, PMID 11472277, PMID 12411815, PMID 12548273, PMID 12560416, PMID 14622770, PMID 17138203, PMID 17413915, PMID 18686750, PMID 18762870, PMID 19157368, PMID 19174373, PMID 19690943, PMID 22506940, PMID 23569691, PMID 23788067, PMID 23878064, PMID 24970272, PMID 24992948, PMID 2589650, PMID 26330019, PMID 26708726, PMID 26759680, PMID 27585532, PMID 27714758, PMID 27787895, PMID 28936712, PMID 31627889, PMID 32619039, PMID 32825817, PMID 33238043, PMID 35193648, PMID 35655234, PMID 38622671, PMID 41133731, PMID 9862240
2009 (1), 2016 (1), 2017 (1), 2018 (1)