Plasma Volume Substitution (Hypovolemia) Including Massive Hemorrhage Clinical Trial
Official title:
Examination of Volume Effect and Safety of 6 % Hydroxyethyl Starch 130/0.4 in Patients Undergoing Major Elective Surgery - an Uncontrolled, Open-labelled, Multi-centre Study
| Verified date | March 2012 |
| Source | Fresenius Kabi |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Pharmaceuticals and Medical Devices Agency |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | December 2010 |
| Est. primary completion date | December 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Japan | Okayama University | Okayama | |
| Japan | Sapporo Medical University, School of Medicine | Sapporo | Hokkaido |
| Japan | National Center for Child Health and Development | Tokyo | |
| Japan | Tokyo Women's Medical University | Tokyo |
| Lead Sponsor | Collaborator |
|---|---|
| Fresenius Kabi Japan |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Volume Effect | Volume effect will be assessed by evaluating the following parameter: 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. Time course of hemodynamic stability |
Saved albumin: during surgery; Time course of hemodynamic stability: from end of surgery until 24 h after surgery | No |
| Secondary | Fluid Balance | Fluid balance = fluid input vs. fluid output | From one day before (pediatric patients)/ immediately before (adults) induction of anesthesia until 48 hours after end of surgery | Yes |
| Secondary | Hemodynamics | From one day before (pediatric patients)/ immediately before (adults) induction of anesthesia until 48 hours after end of surgery | Yes | |
| Secondary | CVP | Central venous pressure (CVP); not mandatory for pediatric patients | Immediately before or after induction of anesthesia (depending on routine procedures), every hour after skin incision, and 2 hours after surgery | Yes |
| Secondary | 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 | Yes | |
| Secondary | 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 | Yes | |
| Secondary | 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 | Yes | |
| Secondary | 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 | Yes | |
| Secondary | ECG | Not mandatory for pediatric patients | Screening, 2 hours and 24 hours after end of surgery | Yes |
| Secondary | Urinalysis | Not mandatory for pediatric patients | Immediately before or after induction of anesthesia (depending on routine procedures) and 24 hours after surgery | Yes |
| Secondary | Local and Systemic Tolerance | After each administration of study drug | Yes | |
| Secondary | (Serious) Adverse Events | From signing informed consent until 28 days follow up | Yes |