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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hemorrhage

Intervention / Treatment
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* Other: Augment O2 Delivery by hemodynamic protocol
* Procedure: High Risk Surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A protocol group receiving augmented Oxygen Delivery will be compared to a usual care group.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Augmented Oxygen Delivery Group<br>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<br>* 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.<br>|
| Sham Comparator: Control<br>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<br>* Patients with same characteristics as Experimental Group having same types of Surgery but no change to usual anesthetic care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| As in the primary |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Improve, Patient care, Applying, Systematic, Fashion, Proven, Resuscitation, Algorithms, High risk, Surgical