Trial of 6% HES130/0.4

Phase 3

Completed

• Conditions: Hypovolemia; Hemorrhage
• Interventions: Drug: 6% hydroxyethyl starch 130/0.4; Drug: 6% hydroxyethyl starch 70/0.5 (Salinhes®)

• Registration Number: NCT01010022
• Lead Sponsor: Fresenius Kabi Japan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-06
• Study First Submitted QC: 2009-11-06
• Study First Posted: 2009-11-09
• Primary Completion: 2010-07
• Study Completion: 2010-11
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-09
• Last Update Posted: 2011-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	6% hydroxyethyl starch 130/0.4	Up to 1000mL 6% hydroxyethyl starch 130/0.4 solution i.v., intra-operatively (from start of surgery until end of surgery)
2	6% hydroxyethyl starch 70/0.5 (Salinhes®)	Up to 1000mL 6% hydroxyethyl starch 70/0.5 (Salinhes®) solution i.v., intra-operatively (from start of surgery until end of surgery)

Primary Outcome Measures

Name	Time	Method
Volume of colloid solution infused during investigational period (= intra-operatively)	Intra-operatively

Secondary Outcome Measures

Name	Time	Method
Fluid input	From immediately before induction of anesthesia until 48 hours after end of surgery
Fluid output	From immediately before induction of anesthesia until 48 hours after end of surgery
Fluid balance	From immediately before induction of anesthesia until 48 hours after end of surgery
Hemodynamics	From immediately before induction of anesthesia until 48 hours after end of surgery
Co-administration of vasoactive drugs	From enrolment until 48 hours after end of surgery

Trial Locations

Locations (7)

Osaka University Graduate School of Medicine; 🇯🇵 Osaka, Japan

Tokyo Women's Medical University; 🇯🇵 Tokyo, Japan

Sapporo Medical University, School of Medicine; 🇯🇵 Sapporo, Hokkaido, Japan

Kyushu University, Graduate School of Medical Sciences; 🇯🇵 Fukuoka, Japan

Kobe University Graduate School of Medicine; 🇯🇵 Kobe, Japan

Okayama University; 🇯🇵 Okayama, Japan

Keio University School of Medicine; 🇯🇵 Tokyo, Japan