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.

Study Overview

• Status: Withdrawn
• Conditions: Hemorrhage
• Intervention / Treatment: Other: Augment O2 Delivery by hemodynamic protocol; Procedure: High Risk Surgery

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC-Presbyterian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Augment O2 Delivery by hemodynamic protocol. (7/30/17: deleted original text which apparently was pasted from an entirely unrelated study having to do with age of transfused blood, presumably by the creator of this record, Cynthia Hatfield, in 2010. SLW)	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. Intervention: High Risk Surgery. (7/30/17: deleted original text which apparently was pasted from an entirely unrelated study having to do with age of transfused blood, presumably by the creator of this record, Cynthia Hatfield, in 2010. SLW)	Procedure: High Risk Surgery; Patients with same characteristics as Experimental Group having same types of Surgery but no change to usual anesthetic care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Duration of mechanical ventilation. Duration of ICU and hospital stay. Infection Renal function. Bowel movement. Oral intake. 3-month period Quality of life.	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
As in the primary	3 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Cheetah Medical Inc.; Hutchinson Technology Inc; LIDCO Limited
• Investigators: Principal Investigator: Steven L Whitehurst, MD, University of Pittsburgh Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2008

Study Registration Dates

• First Submitted: July 22, 2008
• First Submitted That Met QC Criteria: July 28, 2008
• First Posted (Estimate): July 31, 2008

Study Record Updates

• Last Update Posted (Actual): August 1, 2017
• Last Update Submitted That Met QC Criteria: July 30, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Resuscitation; Surgical; High risk; Algorithms; Patient care; Proven; Fashion; Improve; Applying; Systematic
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: Goal Directed Therapy