HypotensionNCT03532919
Heart and Renal Failure in Hip Fracture Surgery
An observational study of Hypotension and Hip Fractures, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
Patients with acute hip fractures are old and vulnerable. With a majoriry classified as being ASA 3 or more. Frequently they receive spinal anesthesia perioperatively inducing hypotension. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypotension, Hip Fractures, Renal Insufficiency
- What is being tested?
- Serum Tropinin
- How many people
- 105 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2018to 1 Dec 2018
- How long will I take part?
- 12 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with an acute hip fracture classified as being ASA 3 or more
Who may be able to join
- Hip fracture patient to be operated upon Classified as being ASA 3 or more
Who cannot join
- Not forfilling inclusion Criterias
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Sahlgrenska University Hospital
Mölndal, Västra Götaland County, 431 80
About this study
Patients with acute hip fractures are old and vulnerable. With a majoriry classified as being ASA 3 or more. Frequently they receive spinal anesthesia perioperatively inducing hypotension. Even a short hypotensive period may induce postop cardiac T roponinT leakage as well as renal failure noted by Changes in Serum Creatinin or Cýstatin C This will be investigated and correlated to intraoperative hypotension as step one. Preliminary this will be followed by an intervention with vasopressor treatment perioperatively to preserve an adequte MABP
Read the detailed description
Patients with acute hip fractures are old and vulnerable. With a majoriry classified as being ASA 3 or more. Frequently they receive spinal anesthesia perioperatively inducing hypotension. Even a short hypotensive period may induce postop cardiac T roponinT leakage as awell as renal failure noted by Changes in S Creatinin or Cýstatin C This will be investigated and correlated to intraoperative hypotension as a step one. Preliminary this will be followed by an intervention with vasopressor treatment perioperatively to preserve an adequte MABP
- Conditions
- Hypotension, Hip Fractures, Renal Insufficiency, Heart Injuries
- Being tested
- Serum Tropinin
- Medical subject headings
- Hypotension, Hip Fractures, Renal Insufficiency, Heart Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum TropininDiagnostic test
Also called Serum Cystatin C
Blodsamples will be taken 4 times from preoperatively to 2 Days postoperatively
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
post surgery
Measured: 90 days
Secondary outcomes (1)
Serum concentrations of Troponin, NTproBNP, Creatinin and Cystatin C
Relations between values and mortality at 30 and 90 days
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start1 Feb 2018
- Primary completion1 Aug 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe 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
- 105 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bengt Nellgard, Sahlgrenska University Hospital
- Investigators
- Bengt M Nellgard, MD PhD, Principal investigator, SahlgrenskaUniversity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532919
- Sponsor's protocol ID
- Refhina
- Status last verified
- Dec 2018
- First submitted
- 10 Apr 2018
- Last updated
- 17 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart and Renal Failure in Hip Fracture Surgery
- ClinicalTrials.gov ID
- NCT03532919
- Acronym / sponsor ID
- Refhina
- Conditions
- Hypotension, Hip Fractures, Renal Insufficiency, Heart Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 22 May 2018 (actual)
- 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 with acute hip fractures are old and vulnerable. With a majoriry classified as being ASA 3 or more. Frequently they receive spinal anesthesia perioperatively inducing hypotension. Even a short hypotensive period may induce postop cardiac T roponinT leakage as well as renal failure noted by Changes in Serum Creatinin or Cýstatin C This will be investigated and correlated to intraoperative hypotension as step one. Preliminary this will be followed by an intervention with vasopressor treatment perioperatively to preserve an adequte MABP
Detailed description
Patients with acute hip fractures are old and vulnerable. With a majoriry classified as being ASA 3 or more. Frequently they receive spinal anesthesia perioperatively inducing hypotension. Even a short hypotensive period may induce postop cardiac T roponinT leakage as awell as renal failure noted by Changes in S Creatinin or Cýstatin C This will be investigated and correlated to intraoperative hypotension as a step one. Preliminary this will be followed by an intervention with vasopressor treatment perioperatively to preserve an adequte MABP
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with an acute hip fracture classified as being ASA 3 or more
Key inclusion criteria (1 listed)
- Hip fracture patient to be operated upon Classified as being ASA 3 or more
Key exclusion criteria (1 listed)
- Not forfilling inclusion Criterias
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 |
|---|---|---|
| Serum TropininAlso: Serum Cystatin CBlodsamples will be taken 4 times from preoperatively to 2 Days postoperatively | Diagnostic test | – |
Primary outcome
Mortality
Time frame: 90 days
post surgery
1 secondary outcome
Serum concentrations of Troponin, NTproBNP, Creatinin and Cystatin C
Time frame: 90 days
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 17 Dec 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Hypotension
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
Hypotension
RecruitingPhase 4
Remimazolam Versus Propofol for Maintenance of Anaesthesia During Major Hepatectomy Under Low Central Venous Pressure
Intraoperative Hypotension, Hepatectomy
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruitingObservational study
Postprandial Hypotension, Frailty and Post-Induction Hypotension in Older Patients Undergoing Noncardiac Surgery
Post-induction Hypotension (PIH), Postprandial Hypotension
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.
Bengt M Nellgard, MD PhD principal investigator
SahlgrenskaUniversity Hospital
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 Hypotension and Hip Fractures, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 1 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 17 Dec 2018. 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 Sweden. 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?
Mortality (time frame: 90 days). 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 17 Dec 2018.