Spinal StenosisPhase 4NCT02271191
Effect of Nicardipine on Renal Function in Deliberate Hypotension
A Phase 4 study testing Nicardipine in people with Spinal Stenosis, run by Yonsei University.
Trial summary
The aim of this study was to demonstrate the effect of nicardipine on renal function with creatinine clearance, serum cystatin C, urine output and fractional excretion of sodium during deliberate hypotension for spine surgery. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Spinal Stenosis
- What is being tested?
- Nicardipine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Jan 2013
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing anterior or posterior spine interbody fusion
Who cannot join
- Patients with American Society of Anesthesiologists physical status III or IV
- Liver dysfunction with aspartate transaminase/alanine transaminase greater than 60/60 IU/L
- Cerebrovascular disease
- Anemia of less than hematocrit 24%
- Diabetes mellitus
- Severe malnutrition
- those diuretics or antihypertensive drugs
About this study
The aim of this study was to demonstrate the effect of nicardipine on renal function with creatinine clearance, serum cystatin C, urine output and fractional excretion of sodium during deliberate hypotension for spine surgery.
Read the detailed description
To induce deliberate hypotension, pharmacological agents such as inhalation anesthetics, calcium channel blockers, beta-adrenergic blockers have been used alone or in combination. Nicardipine, classed as a calcium channel blocker, has a peripheral vasodilator effect via relaxation of smooth muscle fiber and sympathetic nerve inhibition. Nicardipine expands the renal artery and increases glomerular filtration rate. Previous studies reported the renal protective effect of nicardipine in cardiac surgery with cardiopulmonary bypass and robot-assisted laparoscopic surgery.
The aim of this study was to demonstrate the effect of nicardipine on renal function with creatinine clearance , serum cystatin C, urine output and fractional excretion of sodium during deliberate hypotension for spine surgery.
- Conditions
- Spinal Stenosis
- Being tested
- Nicardipine
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicardipineDrug
Also called Perdipine
nicardipine 1-5 ug/kg/min and remifentanil 0.05 ug/kg/min during deliberate hypotension in spine surgery
| Study group | Role | What they receive |
|---|---|---|
| Nicardipine and Remifentanil | Active comparator | intravenous nicardipine and remifentanil during deliberate hypotension Receives: Drug: Nicardipine |
| Remifentanil | Placebo comparator | intravenous remifentanil during deliberate hypotension Receives: Drug: Nicardipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
creatinine clearance
Measured: after deliberate hypotension, and POD1
serum cystatin C
Measured: before deliberate hypotension, after deliberate hypotension, and POD1
urine output
Measured: after deliberate hypotension, and POD1
fractional excretion of sodium
Measured: before deliberate hypotension, after deliberate hypotension, and POD1
Secondary outcomes (1)
Risk, injury, failure, loss, and end stage renal disease (RIFLE) criteria
Measured: before deliberate hypotension, after deliberate hypotension, and POD1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startMay 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chul Ho Chang, MD, PhD, Study chair, Department of Anesthesiology and Pain Medicine, Gangnam Severance Hospital, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, 211 Eonju-ro, Gangnam-gu, Seoul 135-720, Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271191
- Sponsor's protocol ID
- 6-2011-0205
- Status last verified
- Oct 2014
- First submitted
- 15 Oct 2014
- Last updated
- 23 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nicardipine on Renal Function in Deliberate Hypotension
- ClinicalTrials.gov ID
- NCT02271191
- Acronym / sponsor ID
- 6-2011-0205
- Conditions
- Spinal Stenosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 22 Oct 2014 (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.
The aim of this study was to demonstrate the effect of nicardipine on renal function with creatinine clearance, serum cystatin C, urine output and fractional excretion of sodium during deliberate hypotension for spine surgery.
Detailed description
To induce deliberate hypotension, pharmacological agents such as inhalation anesthetics, calcium channel blockers, beta-adrenergic blockers have been used alone or in combination. Nicardipine, classed as a calcium channel blocker, has a peripheral vasodilator effect via relaxation of smooth muscle fiber and sympathetic nerve inhibition. Nicardipine expands the renal artery and increases glomerular filtration rate. Previous studies reported the renal protective effect of nicardipine in cardiac surgery with cardiopulmonary bypass and robot-assisted laparoscopic surgery.
The aim of this study was to demonstrate the effect of nicardipine on renal function with creatinine clearance , serum cystatin C, urine output and fractional excretion of sodium during deliberate hypotension for spine surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicardipine and Remifentanil | Active comparator | Drug: Nicardipineintravenous nicardipine and remifentanil during deliberate hypotension |
| Remifentanil | Placebo comparator | Drug: Nicardipineintravenous remifentanil during deliberate hypotension |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing anterior or posterior spine interbody fusion
Key exclusion criteria (7 listed)
- Patients with American Society of Anesthesiologists physical status III or IV
- Liver dysfunction with aspartate transaminase/alanine transaminase greater than 60/60 IU/L
- Cerebrovascular disease
- Anemia of less than hematocrit 24%
- Diabetes mellitus
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 |
|---|---|---|
| NicardipineAlso: Perdipinenicardipine 1-5 ug/kg/min and remifentanil 0.05 ug/kg/min during deliberate hypotension in spine surgery | Drug | Nicardipine and Remifentanil, Remifentanil |
Primary outcome
creatinine clearance
Time frame: after deliberate hypotension, and POD1
serum cystatin C
Time frame: before deliberate hypotension, after deliberate hypotension, and POD1
urine output
Time frame: after deliberate hypotension, and POD1
fractional excretion of sodium
Time frame: before deliberate hypotension, after deliberate hypotension, and POD1
1 secondary outcome
Risk, injury, failure, loss, and end stage renal disease (RIFLE) criteria
Time frame: before deliberate hypotension, after deliberate hypotension, and POD1
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 23 Oct 2014.
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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.
Chul Ho Chang, MD, PhD study chair
Department of Anesthesiology and Pain Medicine, Gangnam Severance Hospital, Anesthesia and Pain Research Institute, Yonsei University College of Medicine, 211 Eonju-ro, Gangnam-gu, Seoul 135-720, Republic of Korea
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicardipine in people with Spinal Stenosis, run by Yonsei University.
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 1 inclusion and 7 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 23 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
creatinine clearance (time frame: after deliberate hypotension, and POD1). The study lists 4 primary outcomes in all. 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 23 Oct 2014.