Hypovolaemia Due to Acute Blood Loss Clinical Trial
— PHOENICSOfficial title:
Prospective, Randomized, Controlled, Double-blind, Multi-centre, Multinational Study on the Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery
| Verified date | January 2024 |
| Source | Fresenius Kabi |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 2289 |
| Est. completion date | July 6, 2022 |
| Est. primary completion date | April 9, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 41 Years to 85 Years |
| Eligibility | Inclusion: - Male or female adult patients > 40 and = 85 years of age. Women of child bearing potential must test negative on standard pregnancy test (urine or serum) - Patients undergoing elective abdominal surgery with an expected blood loss of = 500 ml - ASA Physical Status II - III - Signed written informed consent form Exclusion: - Hypersensitivity to the active substances or to any of the other excipients of the investigational medicinal products - Body weight = 140 kg - Sepsis - Burns - Renal impairment (AKIN stage = 1 or chronic) or acute and/or chronic renal replacement therapy - Intracranial or cerebral haemorrhage - Critically ill patients (typically admitted to the intensive care unit) - Hyperhydration - Pulmonary oedema - Dehydration - Hyperkalaemia - Severe hypernatraemia - Severe hyperchloraemia - Severely impaired hepatic function - Congestive heart failure - Severe coagulopathy - Organ transplant patients - Metabolic alkalosis - Simultaneous participation in another interventional clinical trial (drugs or medical devices studies) |
| Country | Name | City | State |
|---|---|---|---|
| Austria | General Hospital of Barmherzige Brüder | Sankt Veit | |
| Austria | Social Medical Center East - Donauspital | Vienna | |
| Belgium | Cliniques Universitaires Saint Luc | Brussels | |
| Belgium | AZ Maria Middelares | Gent | |
| Belgium | Jessa Ziekenhuis | Hasselt | |
| Croatia | Clinical Hospital Sveti Duh | Zagreb | |
| Croatia | University Hospital Sisters of Mercy | Zagreb | |
| Croatia | University Hospital Zagreb | Zagreb | |
| Czechia | Kolín Hospital | Kolín | |
| Czechia | Central Military Hospital Prague | Prague | |
| Czechia | General University Hospital in Prague | Prague | |
| Czechia | University Hospital Motol | Prague | |
| France | CHU Angers | Angers | |
| France | Hospital Centre Pierre Oudot | Bourgoin-Jallieu | |
| France | CHRU Lille | Lille | |
| France | Hospital Centre Montauban | Montauban | |
| France | Montpellier University Hospital | Montpellier | |
| France | AP-HP Paris (Salpêtrière) | Paris | |
| France | Hôpital Européen Georges Pompidou | Paris | |
| France | Hospital Saint-Antoine | Paris | |
| France | University Hospital of Strasbourg | Strasbourg | |
| France | Hospital Foch Suresnes | Suresnes | |
| France | Hospital Jean Bernard | Valenciennes | |
| 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 | Kliniken der Stadt Köln | Köln | |
| 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 | |
| Netherlands | Amsterdam Medical Centre | Amsterdam | |
| Netherlands | Martini General Hospital Groningen | Groningen | |
| Netherlands | University Medical Center Groningen | Groningen | |
| Netherlands | University Medical Center (UMC) Maastricht | Maastricht | |
| Poland | University Clinical Center Gdansk | Gdansk | |
| Poland | Medical University of Silesia | Katowice | |
| Poland | Wojewodzki Szpital Zespolony | Konin | |
| Poland | Szpital Specjalistyczny im. Sw. Lukasza | Konskie | |
| Poland | Jagiollonian University Hospital Medical College | Kraków | |
| Poland | Medical University of Lublin | Lublin | |
| Poland | Karol Marcinkowski Medical University in Poznan | Poznan | |
| Poland | University Hospital in Wroclaw | Wroclaw | |
| Poland | Klinika Wisniowa | Zielona Góra | |
| Romania | Fundeni Clinical Institute 1 | Bucharest | |
| Romania | Fundeni Clinical Institute 2 | Bucharest | |
| Romania | University Hospital Elias Bucharest | Bucharest | |
| Romania | Emergency county hospital Cluj | Cluj-Napoca | |
| Spain | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Fresenius Kabi | B. Braun Melsungen AG, European Society of Anaesthesiology and Intensive Care |
Austria, Belgium, Croatia, Czechia, France, Germany, Netherlands, Poland, Romania, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | ||
| Secondary | Renal function | until 1 year after surgery | ||
| Secondary | Calculated red blood cell (RBC) loss | on post-operative day 3 | ||
| Secondary | Estimated intra-operative blood loss | end of surgery | ||
| Secondary | Coagulation | until post-operative day 1 | ||
| Secondary | Inflammation | until post-operative day 1 | ||
| Secondary | Adverse events | until post-operative day 90 | ||
| Secondary | Major post-operative complications | until post-operative day 90 | ||
| Secondary | Mortality | 1 year | ||
| Secondary | Composite of mortality and major post-operative complications (including renal) | until post-operative day 90 | ||
| Secondary | Total volume of administered investigational product | until 24 hours after investigational product treatment start | ||
| Secondary | 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 | ||
| Secondary | Heart Rate | until post-operative day 3 | ||
| Secondary | Body temperature | until post-operative day 3 | ||
| Secondary | Mean arterial pressure | until post-operative day 3, if available | ||
| Secondary | Systolic arterial blood pressure | until end of surgery | ||
| Secondary | Diastolic arterial blood pressure | until end of surgery | ||
| Secondary | Central venous pressure (if available) | until end of surgery | ||
| Secondary | 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 | ||
| Secondary | Partial pressure of carbon dioxide | until end of surgery | ||
| Secondary | Partial pressure of oxygen | until end of surgery | ||
| Secondary | Bicarbonate | until end of surgery | ||
| Secondary | Arterial oxygen saturation | until end of surgery | ||
| Secondary | Haemoglobin | until post-operative day 3 | ||
| Secondary | Haematocrit | until post-operative day 3 | ||
| Secondary | pH | until end of surgery | ||
| Secondary | Base Excess | until end of surgery | ||
| Secondary | Lactate | until post-operative day 3 | ||
| Secondary | Central venous oxygen saturation (if available) | until post-operative day 1 | ||
| Secondary | Serum sodium | until post-operative day 1 | ||
| Secondary | Serum potassium | until post-operative day 1 | ||
| Secondary | Serum calcium | until post-operative day 1 | ||
| Secondary | Serum chloride | until post-operative day 1 | ||
| Secondary | Length of stay in the hospital/intensive care unit | until post-operative day 90 | ||
| Secondary | Hours on mechanical ventilation | until post-operative day 7 |