Prospective, randomized, controlled, double-blind, multicentre, multinational study on the safety and efficacy of 6% Hydroxyethyl starch (HES) solution versus an electrolyte solution in patients undergoing elective abdominal surgery
- Conditions
- 'Hypovolaemia' + 'Decreased blood volume'10014412
- Registration Number
- NL-OMON53031
- Lead Sponsor
- PRA Belgium BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 350
* Male or female adult patients > 40 and * 85 years of age* Women of
childbearing potential must test negative on standard pregnancy test (urine or
serum)* Patients undergoing elective abdominal surgery with an expected blood
loss of * 500 ml* ASA Physical Status II-III* Signed written informed consent
form
* Hypersensitivity to the active substances or to any of the other excipients
of the investigational
* medicinal products* Body weight * 140 kg* Sepsis* Burns* Renal impairment
(AKIN stage * 1 or chronic) or acute and/or chronic renal replacement therapy*
Intracranial or cerebral haemorrhage* Critically ill patients (typically
admitted to the intensive care unit)* Hyperhydration* Pulmonary oedema*
Dehydration* Hyperkalaemia* Severe hypernatraemia* Severe hyperchloraemia*
Severely impaired hepatic function* Congestive heart failure* Severe
coagulopathy* Organ transplant patients* Metabolic alkalosis* Simultaneous
participation in another interventional trial (drugs or medical device)
cacy of HES-containing solutions with re
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method