Pre-emptive Hemodynamic Optimization of High Risk Patients Undergoing Elective Major Surgical Procedures

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Hutchinson Technology Inc
Cheetah Medical Inc.
LIDCO Limited
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00725972
First received: July 22, 2008
Last updated: March 9, 2010
Last verified: March 2010
  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.

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00725972

Contacts
Contact: Steven Whitehurst, MD 412 647 6723 whitehurstsl@anes.upmc.edu
Contact: Ibtesam Hilmi, MB CHB, FRCA 412 647 3262 hilmiia@anes.upmc.edu

Locations
United States, Pennsylvania
UPMC-Presbyterian Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Steven Whitehurst, MD    412-647-3262      
Sponsors and Collaborators
University of Pittsburgh
Hutchinson Technology Inc
Cheetah Medical Inc.
LIDCO Limited
Investigators
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 October 16, 2014