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

July 22, 2008
March 9, 2010
July 2008
May 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00725972 on ClinicalTrials.gov Archive Site
As in the primary [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Pre-emptive Hemodynamic Optimization of High Risk Patients Undergoing Elective Major Surgical Procedures
Pre-emptive Hemodynamic Optimization of High Risk Patients Undergoing Elective Major Surgical Procedures.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Hemorrhage
  • 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.
  • Procedure: High Risk Surgery
    Patients with same characteristics as Experimental Group having same types of Surgery but no change to usual anesthetic care
  • 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.
    Intervention: Other: Augment O2 Delivery by hemodynamic protocol
  • Sham Comparator: Control
    Patients having the same types of surgery but receiving usual anesthetic care.
    Intervention: Procedure: High Risk Surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Not Provided
May 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
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
 
NCT00725972
Goal Directed Therapy
Yes
Department of Anesthesiology and Department of Critical Care Medicine, University of Pittsburgh Medical Center
University of Pittsburgh
  • Hutchinson Technology Inc
  • Cheetah Medical Inc.
  • LIDCO Limited
Principal Investigator: Steven L Whitehurst, MD University of Pittsburgh
University of Pittsburgh
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP