Heart and Renal Failure in Hip Fracture Surgery | NCT03532919

Studies
Heart and Renal Failure in Hip Fracture Surgery

NCT03532919

Sponsor

Sahlgrenska University Hospital

Status

Completed

Last Update Posted

Dec 17, 2018Actual

Enrollment

105Actual

Phase

Not provided

Conditions

Hypotension
Hip Fractures
Renal Insufficiency
Heart Injuries

Interventions

Serum Tropinin

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2018Actual

Primary Completion Date

Aug 1, 2018Actual

Completion Date

Dec 1, 2018Actual

First Submitted Date

Apr 10, 2018

First Submission Date that Met QC Criteria

May 21, 2018

First Posted Date

May 22, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2018

Last Update Posted Date

Dec 17, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bengt Nellgard, Associate professor, Sahlgrenska University HospitalPrincipal Investigator

Lead Sponsor

Sahlgrenska University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

105Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Serum Tropinin	Diagnostic Test	Blodsamples will be taken 4 times from preoperatively to 2 Days postoperatively		Serum Cystatin C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	post surgery	90 days

Secondary Outcomes

Measure	Description	Time Frame
Serum concentrations of Troponin, NTproBNP, Creatinin and Cystatin C	Relations between values and mortality at 30 and 90 days	90 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hip fracture patient to be operated upon Classified as being ASA 3 or more

Exclusion Criteria:

Not forfilling inclusion Criterias

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with an acute hip fracture classified as being ASA 3 or more

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bengt M Nellgard, MD PhD	SahlgrenskaUniversity Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sahlgrenska University Hospital		Mölndal	Västra Götaland County	431 80	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007022	Hypotension
D006620	Hip Fractures
D051437	Renal Insufficiency
D006335	Heart Injuries

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D005264	Femoral Fractures
D050723	Fractures, Bone

Browse Leaves

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Browse Branches

Not provided