Hemorrhage, Hypovolemia
Conditions
Keywords
hypovolemia, surgical blood loss, orthopedic procedures, Treatment of reduced circulating blood volume (hypovolemia) including massive hemorrhage
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.
Interventions
Up to 1000mL 6% hydroxyethyl starch 130/0.4 solution i.v., intra-operatively (from start of surgery until end of surgery)
DRUG6% 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)
Sponsors
Fresenius Kabi Japan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Volume of colloid solution infused during investigational period (= intra-operatively) | Intra-operatively |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Japan
Outcome results
None listed