EUCTR2014-004867-19-AT
Active, not recruiting
Phase 1
Perioperative fluid management in patients receiving major abdominal surgery – Effects of normal saline versus an acetate buffered balanced infusion solution on the necessity of catecholamines for cardiocirculatory support
Clinic for General Anesthesiology, Intensive Care and Pain Management0 sitesJanuary 20, 2015
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Clinic for General Anesthesiology, Intensive Care and Pain Management
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All patients scheduled for open elective major abdominal surgery and expected to last a minimum of 2 hours will be included in the study.
- •Major abdominal surgery includes all gynecological, urological and general surgical operations requiring laparotomy.
- •Major general surgery includes complex visceral resection (surgery involving the liver, esophagus, pancreas or multiple organs), partial or total colectomy, stomach surgery, small bowel resection, open gall\-bladder resection, splenektomie, adrenalektomie and regional lymphnode dissection. Major urological or gynecological surgery includes renal transplant, nephrectomie, visceral resection (ureterectomy, bladder resection, retroperitoneal tumor resection, exenteration), cytoreductive surgery (tumor debulking), radical hysterectomy, radical prostatectomy and open hysterectomy.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 240
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •\-Patients younger than 18 years of age
- •\-Patients unable to give informed consent
- •\-Pregnancy or breastfeeding
- •\-Patients transferred form the intensive care unit to the operating theater
- •\-Patients with an already established catecholamine therapy
- •\-Emergency operation
- •\-Chronic inflammatory diseases (chronic inflammatory rheumatoid diseases, chronic inflammatory renal diseases, chronic inflammatory infectious diseases, chronic inflammatory bowel diseases, chronic liver disease with signs of liver insufficiency)
- •\-Severe cardiovascular disease (heart disease with an ejection fraction below 30%, instable coronary syndroms, severe valvular disease)
- •\-Any signs of infection or sepsis
- •\-Any contraindication for oesophageal Doppler monitoring (oesophageal and aortic pathology, planned oesophageal resection)
Outcomes
Primary Outcomes
Not specified
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