Pre-emptive Hemodynamic Optimization of High Risk Patients Undergoing Elective Major Surgical Procedures
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/2/2016 |
| Start Date: | July 2008 |
| Contact: | Steven Whitehurst, MD |
| Email: | whitehurstsl@anes.upmc.edu |
| Phone: | 412 647 6723 |
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.
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.
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.
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.
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