Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| HE06-024-CP4 | Other Identifier | Fresenius Kabi |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| B. Braun Melsungen AG | INDUSTRY |
| European Society of Anaesthesiology and Intensive Care | OTHER |
Not provided
Not provided
Not provided
Not provided
The aim of the study is to investigate the safety of a 6% HES (Hydroxyethyl Starch) solution (Volulyte 6%) versus an electrolyte solution (Ionolyte) in patients undergoing elective abdominal surgery.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Volulyte 6% | Experimental | Volulyte 6% solution for infusion |
|
| Ionolyte | Active Comparator | Ionolyte solution for infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Volulyte 6% | Drug | Solution for infusion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in mean estimated glomerular filtration rate (eGFR) (calculated from highest cystatin-C levels measured during post-operative days 1-3 (POD 1-3)) between the two treatment groups | post-operative days 1-3 |
| Measure | Description | Time Frame |
|---|---|---|
| Renal function | until 1 year after surgery | |
| Calculated red blood cell (RBC) loss | on post-operative day 3 | |
| Estimated intra-operative blood loss |
Not provided
Inclusion:
Exclusion:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wolfgang F. Buhre, Prof. Dr. med. | Department of Anesthesiology and Pain Management, Maastricht University, The Netherlands | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Barmherzige Brüder | Sankt Veit | Austria | ||||
| Social Medical Center East - Donauspital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41133731 | Derived | Buhre W, Diaz-Cambronero O, Schaefer S, Novacek M, Domingo MS, Stessel B, Rodriguez-Perez A, Richter T, Rohe G, Cholley B, Gruenewald M, Kuiper G, Jaber S, de Korte D, Belda J, de Abreu MG, Baronica R, Scheeren T, Ferrando-Ortola C, Szczeklik W, Tomescu D, Vyzamal T, Gavranovic Z, Argente-Navarro MP, Mazzinari G, Thaler S, Garcia-Gregorio N, Vandenbrande J, Zlotnik D, Wittenstein J, Schmier S, Rohn S, Glasmacher C, Holler M, Jungheinrich C, Niess U, Sessler DI, Westphal M; New Collective Author. Safety and efficacy of 6% hydroxyethyl starch in patients undergoing major surgery: The randomised controlled PHOENICS trial. Eur J Anaesthesiol. 2026 Jan 1;43(1):1-10. doi: 10.1097/EJA.0000000000002307. Epub 2025 Oct 24. | |
| 35193648 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ionolyte | Drug | Solution for infusion |
|
|
| end of surgery |
| Coagulation | until post-operative day 1 |
| Inflammation | until post-operative day 1 |
| Adverse events | until post-operative day 90 |
| Major post-operative complications | until post-operative day 90 |
| Mortality | 1 year |
| Composite of mortality and major post-operative complications (including renal) | until post-operative day 90 |
| Total volume of administered investigational product | until 24 hours after investigational product treatment start |
| Fluid balance [Sum of volume of all intravenous medication (including investigational product and blood products) minus sum of volume of urine output (if available), drainage and estimated intra-operative blood loss] | until post-operative day 3 |
| Heart Rate | until post-operative day 3 |
| Body temperature | until post-operative day 3 |
| Mean arterial pressure | until post-operative day 3, if available |
| Systolic arterial blood pressure | until end of surgery |
| Diastolic arterial blood pressure | until end of surgery |
| Central venous pressure (if available) | until end of surgery |
| Haemodynamics readings as required to determine volume responsiveness [at least one parameter (stroke volume, stroke volume variation, stroke volume index, pulse pressure variation, mean arterial pressure) has to be used to guide volume administration] | until 24 hours after investigational product treatment start |
| Partial pressure of carbon dioxide | until end of surgery |
| Partial pressure of oxygen | until end of surgery |
| Bicarbonate | until end of surgery |
| Arterial oxygen saturation | until end of surgery |
| Haemoglobin | until post-operative day 3 |
| Haematocrit | until post-operative day 3 |
| pH | until end of surgery |
| Base Excess | until end of surgery |
| Lactate | until post-operative day 3 |
| Central venous oxygen saturation (if available) | until post-operative day 1 |
| Serum sodium | until post-operative day 1 |
| Serum potassium | until post-operative day 1 |
| Serum calcium | until post-operative day 1 |
| Serum chloride | until post-operative day 1 |
| Length of stay in the hospital/intensive care unit | until post-operative day 90 |
| Hours on mechanical ventilation | until post-operative day 7 |
| Vienna |
| Austria |
| Cliniques Universitaires Saint Luc | Brussels | Belgium |
| AZ Maria Middelares | Ghent | Belgium |
| Jessa Ziekenhuis | Hasselt | Belgium |
| Clinical Hospital Sveti Duh | Zagreb | Croatia |
| University Hospital Sisters of Mercy | Zagreb | Croatia |
| University Hospital Zagreb | Zagreb | Croatia |
| Kolín Hospital | Kolín | Czechia |
| Central Military Hospital Prague | Prague | Czechia |
| General University Hospital in Prague | Prague | Czechia |
| University Hospital Motol | Prague | Czechia |
| CHU Angers | Angers | France |
| Hospital Centre Pierre Oudot | Bourgoin | France |
| CHRU Lille | Lille | France |
| Hospital Centre Montauban | Montauban | France |
| Montpellier University Hospital | Montpellier | France |
| AP-HP Paris (Salpêtrière) | Paris | France |
| Hospital Saint-Antoine | Paris | France |
| Hôpital Européen Georges Pompidou | Paris | France |
| University Hospital of Strasbourg | Strasbourg | France |
| Hospital Foch Suresnes | Suresnes | France |
| Hospital Jean Bernard | Valenciennes | France |
| Kliniken der Stadt Köln | Cologne | Germany |
| Carl-Thiem-Klinikum | Cottbus | Germany |
| Helios Amper-Klinikum | Dachau | Germany |
| Universitätsklinikum Carl Gustav Carus | Dresden | Germany |
| University Hospital Schleswig-Holstein Campus Kiel | Kiel | Germany |
| University Hospital Marburg | Marburg | Germany |
| University Hospital Munich | München | Germany |
| Universitätsklinikum Münster | Münster | Germany |
| Klinikum Oldenburg AÖR | Oldenburg | Germany |
| Regio Klinikum Pinneberg GmbH | Pinneberg | Germany |
| Amsterdam Medical Centre | Amsterdam | Netherlands |
| Martini General Hospital Groningen | Groningen | Netherlands |
| University Medical Center Groningen | Groningen | Netherlands |
| University Medical Center (UMC) Maastricht | Maastricht | Netherlands |
| University Clinical Center Gdansk | Gdansk | Poland |
| Szpital Specjalistyczny im. Św. Łukasza | Gmina Końskie | Poland |
| Medical University of Silesia | Katowice | Poland |
| Wojewodzki Szpital Zespolony | Konin | Poland |
| Jagiollonian University Hospital Medical College | Krakow | Poland |
| Medical University of Lublin | Lublin | Poland |
| Karol Marcinkowski Medical University in Poznań | Poznan | Poland |
| University Hospital in Wroclaw | Wroclaw | Poland |
| Klinika Wiśniowa | Zielona Góra | Poland |
| Fundeni Clinical Institute 1 | Bucharest | Romania |
| Fundeni Clinical Institute 2 | Bucharest | Romania |
| University Hospital Elias Bucharest | Bucharest | Romania |
| Emergency county hospital Cluj | Cluj-Napoca | Romania |
| Barcelona Clinic Hospital | Barcelona | Spain |
| Hospital Santa Creu i Sant Pau | Barcelona | Spain |
| University Hospital General Del Elche | Elche | Spain |
| Hospital Universitario de Gran Canaria Dr. Negrín | Las Palmas de Gran Canaria | Spain |
| Hospital Gregorio Marañon | Madrid | Spain |
| Hospital Ramón y Cajal | Madrid | Spain |
| Hospital Universitario Fundacion Alcorcon | Madrid | Spain |
| Quironsalud | Málaga | Spain |
| Hospital Clinico Universitario Valencia | Valencia | Spain |
| Hospital Universitari i Politecnic la Fe | Valencia | Spain |
| Hospital Universitario Rio Hortega | Valladolid | Spain |
| Derived |
| Buhre W, de Korte-de Boer D, de Abreu MG, Scheeren T, Gruenewald M, Hoeft A, Spahn DR, Zarbock A, Daamen S, Westphal M, Brauer U, Dehnhardt T, Schmier S, Baron JF, De Hert S, Gavranovic Z, Cholley B, Vymazal T, Szczeklik W, Bornemann-Cimenti H, Soro Domingo MB, Grintescu I, Jankovic R, Belda J. Prospective, randomized, controlled, double-blind, multi-center, multinational study on the safety and efficacy of 6% Hydroxyethyl starch (HES) sOlution versus an Electrolyte solutioN In patients undergoing eleCtive abdominal Surgery: study protocol for the PHOENICS study. Trials. 2022 Feb 22;23(1):168. doi: 10.1186/s13063-022-06058-6. |
| 30017128 | Derived | Chappell D, Jacob M. Should hydroxyethyl starch be banned? Lancet. 2018 Jul 14;392(10142):118. doi: 10.1016/S0140-6736(18)31174-7. No abstract available. |
| ID | Term |
|---|---|
| D006895 | Hydroxyethyl Starch Derivatives |
| ID | Term |
|---|---|
| D013213 | Starch |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005936 | Glucans |
| D011134 | Polysaccharides |
Not provided
Not provided