HemorrhageNCT00725972
Pre-emptive Hemodynamic Optimization of High Risk Patients Undergoing Elective Major Surgical Procedures
A study testing Augment O2 Delivery by hemodynamic protocol and High Risk Surgery in people with Hemorrhage, run by University of Pittsburgh at 1 site in United States.
Trial summary
Several recent clinical trials have documented that early aggressive resuscitation approached guided by defined hemodynamic variables using thoughtful protocols may improve outcome. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemorrhage
- What is being tested?
- Augment O2 Delivery by hemodynamic protocol and High Risk Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult, Male or female.
- Patients undergoing elective major surgery.
- Patients with normal renal function.
- All patients will sign informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC-Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
About this study
Official title: 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.
Read the 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.
- Conditions
- Hemorrhage
- Being tested
- Augment O2 Delivery by hemodynamic protocol, High Risk Surgery
- Keywords
- Improve, Patient care, Applying, Systematic, Fashion, Proven, Resuscitation, Algorithms, High risk, Surgical
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augment O2 Delivery by hemodynamic protocolOther
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.
High Risk SurgeryProcedure or surgery
Patients with same characteristics as Experimental Group having same types of Surgery but no change to usual anesthetic care
| Study group | Role | What they receive |
|---|---|---|
| Augmented Oxygen Delivery Group | Experimental | 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) Receives: Other: Augment O2 Delivery by hemodynamic protocol |
| Control | Sham comparator | 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) Receives: Procedure: High Risk Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of mechanical ventilation. Duration of ICU and hospital stay. Infection Renal function. Bowel movement. Oral intake. 3-month period Quality of life.
Measured: 3 months
Secondary outcomes (1)
As in the primary
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2008 (estimated)
- Study startJul 2008
Why it stopped: termination of funding by sponsors
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A protocol group receiving augmented Oxygen Delivery will be compared to a usual care group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Hutchinson Technology Inc, Cheetah Medical Inc., LIDCO Limited
- Responsible party
- Principal investigator, Hernando Gomez, University of Pittsburgh
- Investigators
- Steven L Whitehurst, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00725972
- Sponsor's protocol ID
- Goal Directed Therapy
- Status last verified
- Jul 2017
- First submitted
- 22 Jul 2008
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-emptive Hemodynamic Optimization of High Risk Patients Undergoing Elective Major Surgical Procedures.
- ClinicalTrials.gov ID
- NCT00725972
- Acronym / sponsor ID
- Goal Directed Therapy
- Conditions
- Hemorrhage
- Keywords
- Improve, Patient care, Applying, Systematic, Fashion, Proven, Resuscitation, Algorithms
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: termination of funding by sponsors
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Hutchinson Technology Inc, Cheetah Medical Inc., LIDCO Limited
- Study start
- Jul 2008 (actual)
- First posted
- 31 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A protocol group receiving augmented Oxygen Delivery will be compared to a usual care group.
| Arm | Type | Receives |
|---|---|---|
| Augmented Oxygen Delivery Group | Experimental | Other: Augment O2 Delivery by hemodynamic protocolHemodynamic 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) |
| Control | Sham comparator | Procedure: High Risk SurgeryPatients 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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult, Male or female.
- Patients undergoing elective major surgery.
- Patients with normal renal function.
- All patients will sign informed consent.
Key exclusion criteria (8 listed)
- Major organ failure.
- Low cardiac output conditions.
- Pulmonary hypertension.
- Severe pulmonary disease.
- Patient refusal to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augment O2 Delivery by hemodynamic protocolHemodynamic 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 | Augmented Oxygen Delivery Group |
| High Risk SurgeryPatients with same characteristics as Experimental Group having same types of Surgery but no change to usual anesthetic care | Procedure or surgery | Control |
Primary outcome
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
1 secondary outcome
As in the primary
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven L Whitehurst, MD principal investigator
University of Pittsburgh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augment O2 Delivery by hemodynamic protocol and High Risk Surgery in people with Hemorrhage, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.