Controlled, international study conducted in several centres on the safety and therapeutic effect of a Hydroxylethyl starch (HES) solution versus an electrolyte solution in patients undergoing elective abdominal surgery

Prospective, randomized, controlled, double-blind, multicentre, multinational study on the safety and efficacy of 6% Hydroxyethyl starch (HES) solution versus an electrolyte solution in patients undergoing elective abdominal surgery - PHOENICS

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002162-30-BE

Enrollment

2280

Registered

2016-08-30

Start date

2017-04-12

Completion date

Unknown

Last updated

2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypovolaemia due to acute blood loss in elective abdominal surgery MedDRA version: 20.0 Level: PT Classification code 10021137 Term: Hypovolaemia System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Volulyte 6% Infusionslösung, Volulyte 6% oplossing voor infusie, Volulyte 6% solution pur perfusion Pharmaceutical Form: Solution for infusion INN or Proposed INN: Hydroxyethyl starch 13

Ionolyte, Infusionslösung

Ionolyte , solution pour perfusion Product Name: Ionolyte Solution for infusion Pharmaceutical Form: Solution for infusion INN or Proposed INN: Sodium chloride CAS Number: 7647-14-5 Other descriptive

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male or female adult patients > 40 and =65 years) yes F.1.3.1 Number of subjects for this age range 780

Exclusion criteria

Exclusion criteria: Hypersensitivity to the active substances or to any of the other excipients of the investigational 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) Dehydration Hyperhydration Pulmonary oedema Congestive heart failure Severe hypernatremia Severe Hyperchloraemia Hyperkalemia Metabolic alkalosis Severely impaired liver function Severe coagulopathy Organ transplant patients Simultaneous participation in another interventional trial (drugs or medical device)

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate non-inferiority regarding the safety of a 6% HES solution (Volulyte 6%) versus an electrolyte solution (Ionolyte) in patients undergoing elective abdominal surgery.;Secondary Objective: Further investigation of safety and efficacy of the applied products;Primary end point(s): 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. This difference will be calculated for the change from the pre-operative baseline value.;Timepoint(s) of evaluation of this end point: Cystatin-C levels will be determined on POD 1-3. eGFR will be calculated from the highest Cystain-C level during this period.	—

Measure

Time frame

Main Objective: To investigate non-inferiority regarding the safety of a 6% HES solution (Volulyte 6%) versus an electrolyte solution (Ionolyte) in patients undergoing elective abdominal surgery.;Secondary Objective: Further investigation of safety and efficacy of the applied products;Primary end point(s): 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. This difference will be calculated for the change from the pre-operative baseline value.;Timepoint(s) of evaluation of this end point: Cystatin-C levels will be determined on POD 1-3. eGFR will be calculated from the highest Cystain-C level during this period.

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Cystatin-C: T0,T2-T8 SCr: T0, T2,T3,T4,T7,T8 Cystatin-C-based eGFR: T0,T2,T3,T4,T7,T8 Cystatin-C-based mean eGFR: T3-T6 SCr-based eGFR: T0, T2, T3, T4, T7, T8 AKIN stage: T0, T2, T3, T4, T7, T8 RIFLE category: T0, T2, T3, T4, T7, T8 Urine output: T0,T1,T3-T4 Coagulation: T0,T2,T3 C-RP: T0,T2,T3 (S)AEs/(S)ARs T0-T8 Blood loss - RBC:T4 & intra-op: T2 LOS-H, LOS-ICU, Fit for discharge - H & ICU: daily MV: T0-T5 Mort. & maj PO comp (+ renal): Cum. from T2 till T8 RRT duration new RRT after POD 7 or H- discharge: T7,T8,T9 IP intake, fluid in-/output, fluid bal: T0-T4 T: T0, T2-T4 HR, MAP, SAP, DAP, CVP: T0, T1 (at least q 30 min), T2-T4 vol guide: during IP admin ABGA: T0 + T2 (all); T3 + T4 (only Hb, Hct, lactate) ScvO2: T0, T2, T3 S Elyte: T0, T2, T3 Maj compl: T3-T8;Secondary end point(s): Safety - Renal function: Cystatin-C, serum creatinine (SCr), Cystatin-C based estimated glomerular filtration rate (eGFR), Cystatin-C based mean eGFR, SCr based eGFR, AKIN score, RIFLE score, unrine output (if available) - Coagulation: Platelet count, International norm ration (INR), activated partial thromboplastin time (aPTT) - Inflammation: C-reactive protein (C-RP) - Adverse events: (serious) adverse events ((S)AEs / reactions ((S)ARs) - Calculated red blood cell (RBC) loss - Estimated intra-operative blood loss - Outcome: Composite of mortality and major post-operative complications (including renal) until day 90, Length of stay (LOS) in the hospital(LOS-H), LOS in the intensive care unit (LOS-ICU); if applicable), fit for discharge from ICU / hospital, hours on mechanical ventilation (MV), mortality (in hospital/out of hospital) and its cause, days on RRT, (new) renal replacement therapy (RRT) Efficacy - Fluid administration: administration of IP volume - Fluid balance: fluid input and output - Haemodynamics / vital signs: temperature (T), heart rate (HR),mean arterial pressure (MAP), systolic arterial blood pressure (SAP), di	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Cystatin-C: T0,T2-T8 SCr: T0, T2,T3,T4,T7,T8 Cystatin-C-based eGFR: T0,T2,T3,T4,T7,T8 Cystatin-C-based mean eGFR: T3-T6 SCr-based eGFR: T0, T2, T3, T4, T7, T8 AKIN stage: T0, T2, T3, T4, T7, T8 RIFLE category: T0, T2, T3, T4, T7, T8 Urine output: T0,T1,T3-T4 Coagulation: T0,T2,T3 C-RP: T0,T2,T3 (S)AEs/(S)ARs T0-T8 Blood loss - RBC:T4 & intra-op: T2 LOS-H, LOS-ICU, Fit for discharge - H & ICU: daily MV: T0-T5 Mort. & maj PO comp (+ renal): Cum. from T2 till T8 RRT duration new RRT after POD 7 or H- discharge: T7,T8,T9 IP intake, fluid in-/output, fluid bal: T0-T4 T: T0, T2-T4 HR, MAP, SAP, DAP, CVP: T0, T1 (at least q 30 min), T2-T4 vol guide: during IP admin ABGA: T0 + T2 (all); T3 + T4 (only Hb, Hct, lactate) ScvO2: T0, T2, T3 S Elyte: T0, T2, T3 Maj compl: T3-T8;Secondary end point(s): Safety - Renal function: Cystatin-C, serum creatinine (SCr), Cystatin-C based estimated glomerular filtration rate (eGFR), Cystatin-C based mean eGFR, SCr based eGFR, AKIN score, RIFLE score, unrine output (if available) - Coagulation: Platelet count, International norm ration (INR), activated partial thromboplastin time (aPTT) - Inflammation: C-reactive protein (C-RP) - Adverse events: (serious) adverse events ((S)AEs / reactions ((S)ARs) - Calculated red blood cell (RBC) loss - Estimated intra-operative blood loss - Outcome: Composite of mortality and major post-operative complications (including renal) until day 90, Length of stay (LOS) in the hospital(LOS-H), LOS in the intensive care unit (LOS-ICU); if applicable), fit for discharge from ICU / hospital, hours on mechanical ventilation (MV), mortality (in hospital/out of hospital) and its cause, days on RRT, (new) renal replacement therapy (RRT) Efficacy - Fluid administration: administration of IP volume - Fluid balance: fluid input and output - Haemodynamics / vital signs: temperature (T), heart rate (HR),mean arterial pressure (MAP), systolic arterial blood pressure (SAP), di

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Countries

Austria, Belgium, Croatia, Czechia, Czech Republic, France, Germany, Italy, Netherlands, Poland, Romania, Serbia, Spain

Contacts

Public ContactUlf Niess

Fresenius Kabi Deutschland GmbH

ulf.niess@fresenius-kabi.com004961726084115

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 19, 2026