ARTHROPLASTY, REPLACEMENT; ANESTHESIANCT02978066
Postspinal Hypotension and Cardiac Performance in the Elderly
An observational study of ARTHROPLASTY, REPLACEMENT; ANESTHESIA, run by Karolinska Institutet.
Trial summary
Patients, scheduled for elective arthroplasty were monitored with Lithium Dilution Cardiac Output monitor (LiDCOplus™) before and 45 minutes after spinal anesthesia. Hypotension was defined as systolic blood pressure ≤ 100 mmHg or ≥ 30% decrease from baseline. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- ARTHROPLASTY, REPLACEMENT; ANESTHESIA
- What is being tested?
- Spinal anaesthesia
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Apr 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged 65 years or older scheduled for hip or knee arthroplasty in spinal anaesthesia. Exclusion criteria were: (i) weight <40kg; (ii) concomitant lithium medication; (iv) informed consent not obtained; (v) research team unavailable
Who may be able to join
- hip or knee arthroplasty
- spinal anaesthesia
- age 65 years or more
Who cannot join
- weight <40kg
- concomitant lithium medication
- written informed consent not obtained
- research team unavailable
About this study
Official title: Is Postspinal Hypotension a Sign of Impaired Cardiac Performance in the Elderly? An Observational Mechanistic Study
Patients, scheduled for elective arthroplasty were monitored with Lithium Dilution Cardiac Output monitor (LiDCOplus™) before and 45 minutes after spinal anesthesia. Hypotension was defined as systolic blood pressure ≤ 100 mmHg or ≥ 30% decrease from baseline. Associations between hypotension and the hemodynamic changes after preanaesthetic fluid loading and spinal anesthesia were analysed by logistic regression analyses.
- Conditions
- ARTHROPLASTY, REPLACEMENT; ANESTHESIA
- Being tested
- Spinal anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anaesthesiaOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke volume in ml
the blood volume pumped by the heart at each stroke
Measured: 0-45 minutes after spinal anaesthesia
Secondary outcomes (1)
Arterial blood pressure mmHg and change from baseline
mmHg measured by arterial catheter
Measured: 0-45 minutes after spinal anaesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startDec 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARTHROPLASTY, REPLACEMENT; ANESTHESIAStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sigridur Kalman, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978066
- Sponsor's protocol ID
- 2010-2042-31/1
- Status last verified
- Sep 2020
- First submitted
- 28 Nov 2016
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Postspinal Hypotension a Sign of Impaired Cardiac Performance in the Elderly? An Observational Mechanistic Study
- ClinicalTrials.gov ID
- NCT02978066
- Acronym / sponsor ID
- 2010-2042-31/1
- Conditions
- ARTHROPLASTY, REPLACEMENT; ANESTHESIA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 30 Nov 2016 (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.
Patients, scheduled for elective arthroplasty were monitored with Lithium Dilution Cardiac Output monitor (LiDCOplus™) before and 45 minutes after spinal anesthesia. Hypotension was defined as systolic blood pressure ≤ 100 mmHg or ≥ 30% decrease from baseline. Associations between hypotension and the hemodynamic changes after preanaesthetic fluid loading and spinal anesthesia were analysed by logistic regression analyses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged 65 years or older scheduled for hip or knee arthroplasty in spinal anaesthesia. Exclusion criteria were: (i) weight <40kg; (ii) concomitant lithium medication; (iv) informed consent not obtained; (v) research team unavailable
Key inclusion criteria (3 listed)
- hip or knee arthroplasty
- spinal anaesthesia
- age 65 years or more
Key exclusion criteria (4 listed)
- weight <40kg
- concomitant lithium medication
- written informed consent not obtained
- research team unavailable
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 |
|---|---|---|
| Spinal anaesthesia | Other | – |
Primary outcome
Stroke volume in ml
Time frame: 0-45 minutes after spinal anaesthesia
the blood volume pumped by the heart at each stroke
1 secondary outcome
Arterial blood pressure mmHg and change from baseline
Time frame: 0-45 minutes after spinal anaesthesia
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 18 Sep 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of ARTHROPLASTY, REPLACEMENT; ANESTHESIA, run by Karolinska Institutet.
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 3 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 18 Sep 2020. 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. 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?
Stroke volume in ml (time frame: 0-45 minutes after spinal anaesthesia). 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 18 Sep 2020.