Trial of 6% HES130/0.4

Fresenius Kabi Japan64 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hypovolemia Hemorrhage

Interventions

6% hydroxyethyl starch 130/0.4DRUG

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)

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (7)

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

Outcomes

Primary Outcomes

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

Time frame: Intra-operatively

Secondary Outcomes

Fluid input

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

Fluid output

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

Fluid balance

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

Hemodynamics

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

Co-administration of vasoactive drugs

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

Data from ClinicalTrials.gov

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