Clinical trial NCT01010022: Trial of 6% HES130/0.4
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypovolemia
Hemorrhage
Keywords: hypovolemia
surgical blood loss
orthopedic procedures
Treatment of reduced circulating blood volume (hypovolemia) including massive hemorrhage
Lead sponsor: Fresenius Kabi
Sponsor class: INDUSTRY
First posted: 2009-11-09
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Volume of colloid solution infused during investigational period (= intra-operatively)
timeFrame: Intra-operatively
Secondary outcomes:
measure: Fluid input
timeFrame: From immediately before induction of anesthesia until 48 hours after end of surgery
measure: Fluid output
timeFrame: From immediately before induction of anesthesia until 48 hours after end of surgery
measure: Fluid balance
timeFrame: From immediately before induction of anesthesia until 48 hours after end of surgery
measure: Hemodynamics
timeFrame: From immediately before induction of anesthesia until 48 hours after end of surgery
measure: Co-administration of vasoactive drugs
timeFrame: From enrolment until 48 hours after end of surgery
Other outcomes:
Locations:
city: Sapporo
country: Japan
facility: Sapporo Medical University, School of Medicine
state: Hokkaido
city: Fukuoka
country: Japan
facility: Kyushu University, Graduate School of Medical Sciences
city: Kobe
country: Japan
facility: Kobe University Graduate School of Medicine
city: Okayama
country: Japan
facility: Okayama University
city: Osaka
country: Japan
facility: Osaka University Graduate School of Medicine
city: Tokyo
country: Japan
facility: Keio University School of Medicine
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University
Study officials:
affiliation: Emeritus Professor, Sapporo Medical University
name: Akiyoshi Namiki, MD, PhD
role: STUDY_CHAIR
References: