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NCT Number: NCT01010022

Trial of 6% HES130/0.4

The study shall evaluate the efficacy and safety of two different hydroxyethyl starch solutions (artificial colloids 6% HES130/0.4 and 6% HES70/0.5, Salinhes®) for intra-operative therapy of hypovolemia and maintenance of circulating blood volume in patients undergoing orthopedic surgery. The primary efficacy endpoint will be the required volume of colloid solution infused from start until end of surgery. It is the aim of the clinical trial to demonstrate that comparable volumes of colloid solution are used between treatment groups.

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Key information

Conditions

Hypovolemia Blood Loss, Surgical Hemorrhage Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sapporo Medical University, School of Medicine, Sapporo, Hokkaido, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with an expected blood loss of ≥ 300 mL undergoing elective orthopedic surgery
  • Patients with a body weight (BW) ≥ 50 kg

Exclusion criteria

  • Known or suspected allergy to hydroxyethyl starch, including its ingredients (inclusive corn) and related drugs
  • ASA classification ≥ IV
  • Renal disease (serum creatinine ≥ 2mg/dL)
  • Known bleeding disorders
  • Congestive heart failure
  • Fluid overload
  • Intracranial bleeding
  • Severe hypernatremia
  • Severe hyperchloremia

Treatment and study plan

6% hydroxyethyl starch 130/0.4

Drug

Up to 1000mL 6% hydroxyethyl starch 130/0.4 solution i.v., intra-operatively (from start of surgery until end of surgery)

6% hydroxyethyl starch 70/0.5 (Salinhes®)

Drug

Up to 1000mL 6% hydroxyethyl starch 70/0.5 (Salinhes®) solution i.v., intra-operatively (from start of surgery until end of surgery)

Primary outcomes

  1. Volume of colloid solution infused during investigational period (= intra-operatively)

    Time frame: Intra-operatively

Secondary outcomes

  1. Fluid input

    Time frame: From immediately before induction of anesthesia until 48 hours after end of surgery

  2. Fluid output

    Time frame: From immediately before induction of anesthesia until 48 hours after end of surgery

  3. Fluid balance

    Time frame: From immediately before induction of anesthesia until 48 hours after end of surgery

  4. Hemodynamics

    Time frame: From immediately before induction of anesthesia until 48 hours after end of surgery

  5. Co-administration of vasoactive drugs

    Time frame: From enrolment until 48 hours after end of surgery

Sponsors and collaborators

Lead sponsor

Fresenius Kabi Japan

Industry

Registry information

Official study title

Examination of Safety and Efficacy of 6% Hydroxyethyl Starch 130/0.4 vs. 6% Hydroxyethyl Starch 70/0.5 in Patients Undergoing Orthopedic Surgery - a Double-blind, Parallel Group, Comparative, Multi-centre Phase III Study

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 9, 2009
Registry last updated
Mar 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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