- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03532919
Heart and Renal Failure in Hip Fracture Surgery
December 14, 2018 updated by: Bengt Nellgård, Sahlgrenska University Hospital, Sweden
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
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
105
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Vastra Gotaland
-
Molndal, Vastra Gotaland, Sweden, 431 80
- Sahlgrenska University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with an acute hip fracture classified as being ASA 3 or more
Description
Inclusion Criteria:
- Hip fracture patient to be operated upon Classified as being ASA 3 or more
Exclusion Criteria:
- Not forfilling inclusion Criterias
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: 90 days
|
post surgery
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum concentrations of Troponin, NTproBNP, Creatinin and Cystatin C
Time Frame: 90 days
|
Relations between values and mortality at 30 and 90 days
|
90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Bengt M Nellgard, MD PhD, SahlgrenskaUniversity Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2018
Primary Completion (Actual)
August 1, 2018
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
April 10, 2018
First Submitted That Met QC Criteria
May 21, 2018
First Posted (Actual)
May 22, 2018
Study Record Updates
Last Update Posted (Actual)
December 17, 2018
Last Update Submitted That Met QC Criteria
December 14, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Kidney Diseases
- Urologic Diseases
- Wounds and Injuries
- Leg Injuries
- Femoral Fractures
- Hip Injuries
- Thoracic Injuries
- Renal Insufficiency
- Fractures, Bone
- Hip Fractures
- Hypotension
- Heart Injuries
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protease Inhibitors
- Cysteine Proteinase Inhibitors
- Cystatins
Other Study ID Numbers
- Refhina
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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