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.
Conditions
Interventions
Trade Name: Voluven
Product Name: Voluven
Pharmaceutical Form: Solution for infusion
CAS Number: 9004-62-0
Concentration unit: g gram(s)
Concentration type: up to
Concentration number: 60-
Pharmaceuti
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
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 ;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 ;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
Exclusion criteria
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. ;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. ;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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To test whether colloid-based goal-directed intraoperative fluid management leads to less perioperative morbidity compared to crystalloid-based goal-directed intraoperative fluid management. ;Secondary Objective: 2. To compare colloid- vs. crystalloid-based goal-directed intraoperative fluid management on the outcome of various organ systems. ;Primary end point(s): We will evaluate post-operative morbidity. This is the primary outcome parameter of the study and will define the stopping point of the study. Postoperative morbidity will be assessed daily with a postoperative morbidity survey [40] by a team member strictly blinded to group assignment. We add mortality end rehospitalization within 30 postoperative days.;Timepoint(s) of evaluation of this end point: refer to 5.1;Main Objective: 1. To test whether colloid-based goal-directed intraoperative fluid management leads to less perioperative morbidity compared to crystalloid-based goal-directed intraoperative fluid management. ;Secondary Objective: 2. To compare colloid- vs. crystalloid-based goal-directed intraoperative fluid management on the outcome of various organ systems. ;Primary end point(s): We will evaluate post-operative morbidity. This is the primary outcome parameter of the study and will define the stopping point of the study. Postoperative morbidity will be assessed daily with a postoperative morbidity survey [40] by a team member strictly blinded to group assignment. We add mortality end rehospitalization within 30 postoperative days.;Timepoint(s) of evaluation of this end point: refer to 5.1;Main Objective: 1. To test whether colloid-based goal-directed intraoperative fluid management leads to less perioperative morbidity compared to crystalloid-based goal-directed intraoperative fluid management. ;Secondary Objective: 2. To compare colloid- vs. crystalloid-based goal-directed intraoperative fluid management on the outcome of various organ systems. ;Primary end point(s): W | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Subcutaneous oxygen tension (PsqO2) will be evaluated intraoperatively in a subgroup of 60 patients with a polarographic-type tissue oxygen sensor (Licox, Inc. Germany) positioned within a subcutaneous, saline filled Silastic® tonometer inserted into the patients’ upper arm after induction of anesthesia. (Silastic® readily permits transfer of oxygen by diffusion.) It has been shown previously, that subcutaneous oxygen tension in the upper arm is comparable to oxygen tension at the side of chest and abdominal wounds though it is about 10 mmHg higher than in the incised wound [41]. The arm is chosen, because it is convenient and can be accessed intraoperatively. The tonometer consists of a Luer-hubbed, 15-cm-long segment of Silastic® tubing (internal diameter, 0,8 mm; external diameter, 1.0 mm). Under controlled conditions, the optode measures p02 accurately and reliably in vitro over a broad range of p02 values and temperatures. In vitro accuracy of the optode (in a water bath at 37 C) is ± 3 mmHg for the range from 0-100 mmHg, and ± 5% for the range 100-360 mmHg. Temperature sensitivity is 0.25%/°C, but a thermistor is incorporated into the probe and temperature-compensation is included in the PsqO2 calculation. The calibration remains stable (within 8% of baseline value for room air) in vitro for at least 72 hours and in vivo for at least 8 hours. The polographic sensor will be initially calibrated, as in our previous studies, by exposing it to room air (pO2=154 mmHg). It will then be inserted into the Silastic® tonometer, which will be flushed with hypoxic saline to provide more rapid equilibration with the surrounding tissue. The optode will be allowed to equilibrate with tissue oxygen for at least 30 minutes. It was shown that this time period is sufficient for any clinically observed PsqO2. It also was shown that PsqO2 values correlate well with the incidence of clinically significant wound infections. Measurements will start as soon | — |
Countries
Austria, United States
Contacts
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Outcome results
None listed