Pre-emptive Hemodynamic Optimization of High Risk Patients Undergoing Elective Major Surgical Procedures
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Several recent clinical trials have documented that early aggressive resuscitation approached guided by defined hemodynamic variables using thoughtful protocols may improve outcome. The concept underscored by this newer trial was that appropriate resuscitation prevents subsequent tissue injury even if overt shock is present, if the resuscitation is carried out early enough.
| Condition | Intervention |
|---|---|
|
Hemorrhage |
Other: Augment O2 Delivery by hemodynamic protocol Procedure: High Risk Surgery |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Pre-emptive Hemodynamic Optimization of High Risk Patients Undergoing Elective Major Surgical Procedures. |
- Duration of mechanical ventilation. Duration of ICU and hospital stay. Infection Renal function. Bowel movement. Oral intake. 3-month period Quality of life. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- As in the primary [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 200 |
| Study Start Date: | July 2008 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Augmented Oxygen Delivery Group
Hemodynamic management to a goal of O2 delivery of 600 ml/m2/min utilizing cardiac stroke volume variation with positive pressure ventilation to optimize fluid management.
|
Other: Augment O2 Delivery by hemodynamic protocol
Hemodynamic management to a goal of O2 delivery of 600 ml/m2/min utilizing cardiac stroke volume variation with positive pressure ventilation to optimize fluid management.
|
|
Sham Comparator: Control
Patients having the same types of surgery but receiving usual anesthetic care.
|
Procedure: High Risk Surgery
Patients with same characteristics as Experimental Group having same types of Surgery but no change to usual anesthetic care
|
Detailed Description:
This is a randomized, prospective study which will include a total of 200 patients who are scheduled to undergo major elective surgery with an anticipated blood loss of ≥ 500 ml. The research participants will be randomly assigned to a control group (n=100) that will receive the standard of care for intraoperative management by the anesthesia. Minimal resuscitation standards include a mean arterial pressure > 65 mm Hg, SpO2 > 90% and evidence of end-organ perfusion (i.e. mentation prior to induction of anesthesia, urine output > 20 ml/hr) and absence of tachycardia (HR < 100/min). The protocol group (n=100) will, in addition, receive further resuscitation to achieve an increased oxygen delivery (DO2) to a targeted of 600 ml/min/m2. This approach is called goal-directed therapy. This target DO2 will be achieved via a treatment algorithm that includes intraoperative volume expansion and/or dobutamine infusion, guided by the LiDCO cardiovascular monitoring of stroke volume and cardiac output. All patients will also have non-invasive tissue O2 saturation (StO2) monitoring using the InSpectra probe on their hand. Patients in the protocol group will be subdivided to 2 subgroups. Group one subjects will be those patients that are directly admitted to the ICU following surgery and group two subjects will be those patients discharged to the PAR and then a regular hospital ward. All subjects will continue to receive goal directed therapy for as long as they are in the PAR or ICU or until 8 hours of post-operative time has elapsed. All participants will be followed daily during their hospital stay to assess the development of complications, length of stay and discharge status. All patients will receive phone interview at one and 3 months after the surgery to inquire about their quality of life since their surgery using the SF36 instrument. The total duration of participant's commitment to the study will be 3 months, during which their lab and clinical data will be recorded. Statistical analysis of the data will be performed at the conclusion of the study period by professional statistician to determine the difference in the outcome and morbidity and mortality between the two groups using multiple logistic regression and Cox proportional hazard scoring with primary outcome variables being length of stay, total complications, and mortality.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult, Male or female.
- Patients undergoing elective major surgery.
- Patients with normal renal function.
- All patients will sign informed consent.
Exclusion Criteria:
- Major organ failure.
- Low cardiac output conditions.
- Pulmonary hypertension.
- Severe pulmonary disease.
- Patient refusal to participate in the study.
- Pregnancy.
- Emergency Surgery.
- Lithium allergy or patient on lithium.
Contacts and Locations| Contact: Steven Whitehurst, MD | 412 647 6723 | whitehurstsl@anes.upmc.edu |
| Contact: Ibtesam Hilmi, MB CHB, FRCA | 412 647 3262 | hilmiia@anes.upmc.edu |
| United States, Pennsylvania | |
| UPMC-Presbyterian Hospital | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Steven Whitehurst, MD 412-647-3262 | |
| Principal Investigator: | Steven L Whitehurst, MD | University of Pittsburgh |
More Information
No publications provided
| Responsible Party: | Department of Anesthesiology and Department of Critical Care Medicine, University of Pittsburgh Medical Center |
| ClinicalTrials.gov Identifier: | NCT00725972 History of Changes |
| Other Study ID Numbers: | Goal Directed Therapy |
| Study First Received: | July 22, 2008 |
| Last Updated: | March 9, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pittsburgh:
|
Improve Patient care Applying Systematic Fashion |
Proven Resuscitation Algorithms High risk Surgical |
Additional relevant MeSH terms:
|
Hemorrhage Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013