Study to Obtain Volume Effect and Safety Data on 6 % Hydroxyethyl Starch 130/0.4 in Pediatric and Adult Patients Undergoing Major Elective Surgery

NCT01127477 | Completed Phase 3

• 1 other identifier: HE06-008-CP3
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

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.

Conditions

Plasma Volume Substitution (Hypovolemia) Including Massive Hemorrhage

Keywords

Hypovolemia, surgical blood loss

Outcome Measures

Primary Outcomes (1)

• Volume Effect

  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

  Saved albumin: during surgery; Time course of hemodynamic stability: from end of surgery until 24 h after surgery

Secondary Outcomes (11)

• Fluid Balance

  From one day before (pediatric patients)/ immediately before (adults) induction of anesthesia until 48 hours after end of surgery

• 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

• 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

Study Arms (1)

1

EXPERIMENTAL

Drug: 1: Hydroxyethyl starch 130/0.4, 6 %

Interventions

1: Hydroxyethyl starch 130/0.4, 6 % DRUG

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.

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fresenius Kabi Japan: lead

Study Sites (4)

Sapporo Medical University, School of Medicine

Sapporo, Hokkaido, 060-8543, Japan

Location

Okayama University

Okayama, 700-8558, Japan

Location

National Center for Child Health and Development

Tokyo, 157-8535, Japan

Location

Tokyo Women's Medical University

Tokyo, 162-8666, Japan

Location

MeSH Terms

Conditions

Hypovolemia; Blood Loss, Surgical

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hemorrhage; Intraoperative Complications

Study Officials

• Akiyoshi Namiki, MD, PhD

  Emeritus Professor Sapporo Medical University; CEO, Otaru City Hospitals, Hokkaido, Japan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2010
• First Posted: May 21, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 26, 2012

Record last verified: 2012-03

Locations

JP (4)