A comparison of crystalloids vs. colloids for intraoperative goal-directed fluid management

Phase 1

• Conditions: Fluid optimization has been considered as major contributor to improved oxygen delivery, and thus improved outcome in patients. Hypovolemia has been associated with significant increases in morbidity and mortality. Administering volume deliberately, however, also may have undesired effects like hemodynamic deterioration, pulmonary edema, tissue edema, and decreased O2-delivery.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2005-004602-86-AT
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-17
• Last Update Posted: 13 February 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1112

Inclusion Criteria

After IRB approval and written informed consent patients aged 18 to 80 and scheduled for elective open abdominal surgery, open hysterectomy or myomectomy, or open urologic surgery (open prostatectomies and open cystectomies with ileal conduit formation) will be included in the study. Patients will be assigned to two groups:
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
;
After IRB approval and written informed consent patients aged 18 to 80 and scheduled for elective open abdominal surgery, open hysterectomy or myomectomy, or open urologic surgery (open prostatectomies and open cystectomies with ileal conduit formation) will be included in the study. Patients will be assigned to two groups:
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
;
After IRB approval and written informed consent patients aged 18 to 80 and scheduled for elective open abdominal surgery, open hysterectomy or myomectomy, or open urologic surgery (open prostatectomies and open cystectomies with ileal conduit formation) will be included in the study. Patients will be assigned to two groups:
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

We will exclude patients having cardiac (EF<35%) or renal insufficiency (creatinine clearance < 30ml/min, or on renal replacement therapy), coronary (NYHA IV) or peripheral artery disease, COPD, coagulopathies, symptoms of infection or sepsis, or a history of susceptibility to malignant hyperthermia or porphyria. Participants in other studies will be excluded, when an interference of the studies cannot be ruled out. Operating Room records indicate that sufficient qualifying patients will be available to complete the proposed studies within the requested timetable.
;
We will exclude patients having cardiac (EF<35%) or renal insufficiency (creatinine clearance < 30ml/min, or on renal replacement therapy), coronary (NYHA IV) or peripheral artery disease, COPD, coagulopathies, symptoms of infection or sepsis, or a history of susceptibility to malignant hyperthermia or porphyria. Participants in other studies will be excluded, when an interference of the studies cannot be ruled out. Operating Room records indicate that sufficient qualifying patients will be available to complete the proposed studies within the requested timetable.
;
We will exclude patients having cardiac (EF<35%) or renal insufficiency (creatinine clearance < 30ml/min, or on renal replacement therapy), coronary (NYHA IV) or peripheral artery disease, COPD, coagulopathies, symptoms of infection or sepsis, or a history of susceptibility to malignant hyperthermia or porphyria. Participants in other studies will be excluded, when an interference of the studies cannot be ruled out. Operating Room records indicate that sufficient qualifying patients will be available to complete the proposed studies within the requested timetable.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified