HypertensionHTNNCT01140854
Cognitive Dysfunction in Hypertensive Patients Having Spine Surgery
An observational study of Hypertension, run by Columbia University at 1 site in United States.
Trial summary
While hypotension during general anesthesia has routinely been considered to be a tolerable abnormality with little clinical consequence, the proposed study takes the innovative approach of defining hypotensive events within the construct of a patient's own hypertensive status, fractional mean arterial blood pressure… Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Lumbar spine surgery and Neurologic/neuropsychometric examinations
- Type of treatment
- Surgery or procedure
- How many people
- 179 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Dec 2014
- Phase
- Observational
- 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 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients >60 years old will be recruited who are scheduled for elective simple spine surgery (microdiskectomy or 1-2 level laminectomies without fusion) and lasting <5 hours without blood transfusion.
Who may be able to join
- elective spine surgery
- > 60 years old
- < 5 hours of surgery
- microdiskectomy
- 1-2 levels of spinal laminectomies
Who cannot join
- transfusions
- > 5 hours of surgery
- > 2 levels of laminectomies
- spinal instrumentation
Trial locations and contacts
1 site in 1 country.
About this study
While hypotension during general anesthesia has routinely been considered to be a tolerable abnormality with little clinical consequence, the proposed study takes the innovative approach of defining hypotensive events within the construct of a patient's own hypertensive status, fractional mean arterial blood pressure (fMAP). Because the investigators primary variable is within the control of anesthesia personnel, the study portends a potentially simple and easy to implement treatment. The introduction of neuropsychometric measures as the relevant evaluator of post-operative cognitive dysfunction is innovative, and may be more relevant to the average elderly patient than simple mortality.
Read the detailed description
After major non-cardiac and non-cerebral surgery, postoperative cognitive dysfunction (POCD) occurs in a significant percentage of patients. The consequences of POCD are profound. Elderly patients having POCD at 1 week have an increased risk of disability or voluntary early retirement, and patients having POCD at 3 months have increased mortality.
The effect of low arterial blood pressure, called hypotension, during surgery on the incidence of POCD is not obvious. This effect has been obscured in a number of previous studies because, it was assumed that hypotension had to persist for minutes to hours to be deleterious, when, in fact, the duration is uncertain. In addition, patient outcomes were not analyzed as a function of a history of hypertension. In this research application, the investigators focus specifically on patients with a history of hypertension because their physiology is different than patients with normal arterial blood pressure. These hypertensive patients may be unable to compensate for low arterial blood pressure by a process called cerebral autoregulation. As a result, patients with a history of hypertension may be at greater risk for decreased cerebral perfusion and cerebral ischemia secondary to decreased systemic arterial blood pressure even during surgery for procedures not thought to put the brain at risk of ischemia.
In a prior retrospective study, the investigators analyzed hemodynamic data from fifty elderly (average age >60 years) patients having simple lumbar spine surgery, which is not thought to be associated with cerebral ischemia. These patients were all examined with a battery of neuropsychometric tests before and after surgery. Patients with a history of hypertension had cognitive changes that are dependent on the lowest fractional mean arterial blood pressure (fMAP), where fMAP is mean arterial blood pressure (MAP) divided by baseline MAP. Such changes were not found in patients without a history of hypertension. This relationship did not depend on the steady state fMAP or the highest fMAP reached in either group.
To confirm and extend these results the investigators therefore propose and hypothesize that: In patients with a history of hypertension, compared to patients without this history, low fMAPs during induction predict cognitive performance after surgery.
To evaluate these hypotheses the investigators will determine the incidence of post-operative cognitive dysfunction (POCD) as a function of the fMAP in hypertensive and normotensive patients undergoing elective simple lumbar spine surgery.
If the proposed study demonstrates that acute intra-operative episodes of hypotension are deleterious to cognitive performance in patients with hypertension, and that there are demonstrable consequences in terms of QOL measures, the possibility of a direct and low cost intervention will be available that will lead directly to an efficacy trial using non-invasive measures of cerebral blood flow algorithms to prevent POCD.
The investigators plan to conduct a multicenter study in which 200 elderly patients (>60 years) are tested with a validated battery of 6 neuropsychometric tests before simple elective lumbar spine surgery (microdiscectomy or 1-2 level laminectomies without fusions lasting <5 hours and not requiring blood transfusions) and two times after surgery, at 24 hours and at 1 month. Two questionnaires for QOL will be performed before surgery and at 1 month. Patients will be questioned whether they have a history of hypertension, and, if they do, then its duration and treatment.
Our analysis will be based on comparing the fMAP to the neuropsychometric performance before and after surgery. To see if neuropsychometric changes occur as a component of a routine anesthetic, anesthesiologists will not be given a specific protocol for intraoperative management.
The primary outcome measure will be changes in test performance between baseline and the post-operative period at 1 day and 1 month. This primary measure will be a rating of overall change in performance compared to three values of fMAPs: lowest, steady state and highest fMAP attained. Our analysis will also include uni- and multi-variate analyses which will include and QOL.
- Conditions
- Hypertension
- Being tested
- Lumbar spine surgery, Neurologic/neuropsychometric examinations
- Keywords
- hypertension, hypotension, cognitive, neurocognitive, cognitive dysfunction, postoperative cognitive dysfunction (POCD), neuropsychometric
- Medical subject headings
- Hypertension, Hypotension, Cognitive Dysfunction, Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar spine surgeryProcedure or surgery
(non-experimental) we do not intend to change the criteria of selection for simple lumbar spine surgery, anesthesia, or the postoperative management of the patients studied.
Neurologic/neuropsychometric examinationsOther
To measure postoperative cognitive dysfunction.
| Study group | Role | What they receive |
|---|---|---|
| Hypertension (case) | Elderly patients 60 years old or older undergoing simple lumbar spine surgery under general anesthesia will receive neurologic/neuropsychometric examinations. Receives: Procedure: Lumbar spine surgery; Other: Neurologic/neuropsychometric examinations | |
| Normotension (control) | Middle-aged patients (40-60 years) undergoing simple lumbar spine surgery under general anesthesia as controls to compare their performance to those patients >60 years - will also receive neurologic/neuropsychometric examinations. Receives: Procedure: Lumbar spine surgery; Other: Neurologic/neuropsychometric examinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychometric changes at 1 day
The investigators will determine whether there are neuropsychometric changes associated with simple spine surgery as a function of arterial blood pressure measurements relative to the patient's baseline values at 1 day.
Measured: Baseline to 1 Day
Secondary outcomes (1)
Neuropsychometric changes at 1 Month
The investigators will determine whether there are neuropsychometric changes associated with simple spine surgery as a function of arterial blood pressure measurements relative to the patient's baseline values at 1 month.
Measured: Baseline to 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study startJan 2009
- Primary completionJan 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Responsible party
- Principal investigator, Eric J. Heyer, MD, PhD, Columbia University
- Investigators
- Eric J Heyer, MD, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140854
- Sponsor's protocol ID
- AAAD3838
- Acronym
- HTN
- Status last verified
- Jun 2015
- First submitted
- 2 Jun 2010
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Yocum GT, Gaudet JG, Teverbaugh LA, Quest DO, McCormick PC, Connolly ES Jr, Heyer EJ. Neurocognitive performance in hypertensive patients after spine surgery. Anesthesiology. 2009 Feb;110(2):254-61. doi: 10.1097/ALN.0b013e3181942c7a.
PubMed 19194152
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Dysfunction in Hypertensive Patients Having Spine Surgery
- ClinicalTrials.gov ID
- NCT01140854
- Acronym / sponsor ID
- HTN / AAAD3838
- Conditions
- Hypertension
- Keywords
- hypertension, hypotension, cognitive, neurocognitive, cognitive dysfunction, postoperative cognitive dysfunction (POCD), neuropsychometric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Study start
- Jan 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 10 Jun 2010 (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.
While hypotension during general anesthesia has routinely been considered to be a tolerable abnormality with little clinical consequence, the proposed study takes the innovative approach of defining hypotensive events within the construct of a patient's own hypertensive status, fractional mean arterial blood pressure (fMAP). Because the investigators primary variable is within the control of anesthesia personnel, the study portends a potentially simple and easy to implement treatment. The introduction of neuropsychometric measures as the relevant evaluator of post-operative cognitive dysfunction is innovative, and may be more relevant to the average elderly patient than simple mortality.
Detailed description
After major non-cardiac and non-cerebral surgery, postoperative cognitive dysfunction (POCD) occurs in a significant percentage of patients. The consequences of POCD are profound. Elderly patients having POCD at 1 week have an increased risk of disability or voluntary early retirement, and patients having POCD at 3 months have increased mortality.
The effect of low arterial blood pressure, called hypotension, during surgery on the incidence of POCD is not obvious. This effect has been obscured in a number of previous studies because, it was assumed that hypotension had to persist for minutes to hours to be deleterious, when, in fact, the duration is uncertain. In addition, patient outcomes were not analyzed as a function of a history of hypertension. In this research application, the investigators focus specifically on patients with a history of hypertension because their physiology is different than patients with normal arterial blood pressure. These hypertensive patients may be unable to compensate for low arterial blood pressure by a process called cerebral autoregulation. As a result, patients with a history of hypertension may be at greater risk for decreased cerebral perfusion and cerebral ischemia secondary to decreased systemic arterial blood pressure even during surgery for procedures not thought to put the brain at risk of ischemia.
In a prior retrospective study, the investigators analyzed hemodynamic data from fifty elderly (average age >60 years) patients having simple lumbar spine surgery, which is not thought to be associated with cerebral ischemia. These patients were all examined with a battery of neuropsychometric tests before and after surgery. Patients with a history of hypertension had cognitive changes that are dependent on the lowest fractional mean arterial blood pressure (fMAP), where fMAP is mean arterial blood pressure (MAP) divided by baseline MAP. Such changes were not found in patients without a history of hypertension. This relationship did not depend on the steady state fMAP or the highest fMAP reached in either group.
To confirm and extend these results the investigators therefore propose and hypothesize that: In patients with a history of hypertension, compared to patients without this history, low fMAPs during induction predict cognitive performance after surgery.
To evaluate these hypotheses the investigators will determine the incidence of post-operative cognitive dysfunction (POCD) as a function of the fMAP in hypertensive and normotensive patients undergoing elective simple lumbar spine surgery.
If the proposed study demonstrates that acute intra-operative episodes of hypotension are deleterious to cognitive performance in patients with hypertension, and that there are demonstrable consequences in terms of QOL measures, the possibility of a direct and low cost intervention will be available that will lead directly to an efficacy trial using non-invasive measures of cerebral blood flow algorithms to prevent POCD.
The investigators plan to conduct a multicenter study in which 200 elderly patients (>60 years) are tested with a validated battery of 6 neuropsychometric tests before simple elective lumbar spine surgery (microdiscectomy or 1-2 level laminectomies without fusions lasting <5 hours and not requiring blood transfusions) and two times after surgery, at 24 hours and at 1 month. Two questionnaires for QOL will be performed before surgery and at 1 month. Patients will be questioned whether they have a history of hypertension, and, if they do, then its duration and treatment.
Our analysis will be based on comparing the fMAP to the neuropsychometric performance before and after surgery. To see if neuropsychometric changes occur as a component of a routine anesthetic, anesthesiologists will not be given a specific protocol for intraoperative management.
The primary outcome measure will be changes in test performance between baseline and the post-operative period at 1 day and 1 month. This primary measure will be a rating of overall change in performance compared to three values of fMAPs: lowest, steady state and highest fMAP attained. Our analysis will also include uni- and multi-variate analyses which will include and QOL.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypertension (case) | – | Procedure: Lumbar spine surgery, Other: Neurologic/neuropsychometric examinationsElderly patients 60 years old or older undergoing simple lumbar spine surgery under general anesthesia will receive neurologic/neuropsychometric examinations. |
| Normotension (control) | – | Procedure: Lumbar spine surgery, Other: Neurologic/neuropsychometric examinationsMiddle-aged patients (40-60 years) undergoing simple lumbar spine surgery under general anesthesia as controls to compare their performance to those patients >60 years - will also receive neurologic/neuropsychometric examinations. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients >60 years old will be recruited who are scheduled for elective simple spine surgery (microdiskectomy or 1-2 level laminectomies without fusion) and lasting <5 hours without blood transfusion.
Key inclusion criteria (5 listed)
- elective spine surgery
- > 60 years old
- < 5 hours of surgery
- microdiskectomy
- 1-2 levels of spinal laminectomies
Key exclusion criteria (4 listed)
- transfusions
- > 5 hours of surgery
- > 2 levels of laminectomies
- spinal instrumentation
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 |
|---|---|---|
| Lumbar spine surgery(non-experimental) we do not intend to change the criteria of selection for simple lumbar spine surgery, anesthesia, or the postoperative management of the patients studied. | Procedure or surgery | Hypertension (case), Normotension (control) |
| Neurologic/neuropsychometric examinationsTo measure postoperative cognitive dysfunction. | Other | Hypertension (case), Normotension (control) |
Primary outcome
Neuropsychometric changes at 1 day
Time frame: Baseline to 1 Day
The investigators will determine whether there are neuropsychometric changes associated with simple spine surgery as a function of arterial blood pressure measurements relative to the patient's baseline values at 1 day.
1 secondary outcome
Neuropsychometric changes at 1 Month
Time frame: Baseline to 1 Month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
- Results publication: PubMed 19194152Yocum GT, Gaudet JG, Teverbaugh LA, Quest DO, McCormick PC, Connolly ES Jr, Heyer EJ. Neurocognitive performance in hypertensive patients after spine surgery. Anesthesiology. 2009 Feb;110(2):254-61. doi: 10.1097/ALN.0b013e3181942c7a.
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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.
Eric J Heyer, MD, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Columbia University 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 4 Jun 2015. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Neuropsychometric changes at 1 day (time frame: Baseline to 1 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01140854, which also lists 1 linked publication.
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 4 Jun 2015.