Plasma Volume Substitution (Hypovolemia) Including Massive Hemorrhage
Conditions
Keywords
Hypovolemia, surgical blood loss
Brief summary
The study shall evaluate the volume effect and safety of 6 % hydroxyethyl starch 130/0.4 for restoration and maintenance of hemodynamics during the investigational period in patients undergoing major elective surgery. Up to 50 mL 6% hydroxyethyl starch/kg body weight will be administered from start of surgery until two hours after end of surgery. The study hypothesis is that 6 % hydroxyethyl starch 130/0.4 will have a reliable volume effect and can be safely administered up to the dose limit.
Interventions
DRUG1: Hydroxyethyl starch 130/0.4, 6 %
1: Up to 50 ml 6 % hydroxyethyl starch 130/0.4/kg body weight administered intravenously from start of surgery (skin incision) until two hours after end of surgery.
Sponsors
Fresenius Kabi Japan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients undergoing major elective surgery * Adults patients (≥20 years of age): expected blood loss of ≥ 1000mL Pediatric patients (\<20 years of age): expected blood loss ≥ 15 mL/kg * Adult patients: Routine measurement of Central Venous Pressure (CVP)
Exclusion criteria
* Known or suspected allergy to hydroxyethyl starch, including its ingredients (inclusive corn) and related drugs * ASA classification ≥ IV * Adult patients: renal failure with oliguria (\<400 mL urin /24hours) and anuria Pediatric patients: renal failure with oliguria and anuria not related to hypovolemia * Known bleeding disorders * Other contra-indications according to the current SmPC of Voluven 6% solution for infusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume Effect | Saved albumin: during surgery; Time course of hemodynamic stability: from end of surgery until 24 h after surgery | Volume effect will be assessed by evaluating the following parameter: 1. Saved albumin: For adult patients: Amount of 6 % hydroxyethyl starch 130/0.4 (HES130) administered during surgery once 1000 mL of HES130 are exceeded. For pediatric patients: Amount of HES130 administered during surgery once 10 mL HES130/kg body weight are exceeded. 2. Time course of hemodynamic stability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamics | From one day before (pediatric patients)/ immediately before (adults) induction of anesthesia until 48 hours after end of surgery | — |
| CVP | Immediately before or after induction of anesthesia (depending on routine procedures), every hour after skin incision, and 2 hours after surgery | Central venous pressure (CVP); not mandatory for pediatric patients |
| Hematology | One day before (pediatric patients)/ immediately before (adults) induction of anesthesia, every hour after skin incision (adults), end of surgery (adults), 2 hours and 24 hours after end of surgery | — |
| Clinical Chemistry | One day before (pediatric patients)/ immediately before (adults) induction of anesthesia, end of surgery (adults), 2 hours after end of surgery (pediatric patients), and 24 hours after end of surgery | — |
| Hemostasis | One day before (pediatric patients)/ immediately before (adults) induction of anesthesia, end of surgery (adults), 2 hours and 24 hours after end of surgery | — |
| Fluid Balance | From one day before (pediatric patients)/ immediately before (adults) induction of anesthesia until 48 hours after end of surgery | Fluid balance = fluid input vs. fluid output |
| ECG | Screening, 2 hours and 24 hours after end of surgery | Not mandatory for pediatric patients |
| Urinalysis | Immediately before or after induction of anesthesia (depending on routine procedures) and 24 hours after surgery | Not mandatory for pediatric patients |
| Local and Systemic Tolerance | After each administration of study drug | — |
| (Serious) Adverse Events | From signing informed consent until 28 days follow up | — |
| Body Temperature | One day before (pediatric patients)/ immediately before (adults) induction of anesthesia, end of surgery, 2 hours and 24 hours after end of surgery | — |
Countries
Japan
Outcome results
None listed