NCT03532919

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 22, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

December 17, 2018

Status Verified

December 1, 2018

Enrollment Period

6 months

First QC Date

April 10, 2018

Last Update Submit

December 14, 2018

Conditions

HypotensionHip FracturesRenal InsufficiencyHeart Injuries

Outcome Measures

Primary Outcomes (1)

  • Mortality

    post surgery

    90 days

Secondary Outcomes (1)

  • Serum concentrations of Troponin, NTproBNP, Creatinin and Cystatin C

    90 days

Interventions

Serum TropininDIAGNOSTIC_TEST

Blodsamples will be taken 4 times from preoperatively to 2 Days postoperatively

Also known as: Serum Cystatin C

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Mölndal, Västra Götaland County, 431 80, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Laboratory samples on Creatinin Cystatin C NTproBNP and Troponin T

MeSH Terms

Conditions

HypotensionHip FracturesRenal InsufficiencyHeart Injuries

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesThoracic Injuries

Study Officials

  • Bengt M Nellgard, MD PhD

    SahlgrenskaUniversity Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

April 10, 2018

First Posted

May 22, 2018

Study Start

February 1, 2018

Primary Completion

August 1, 2018

Study Completion

December 1, 2018

Last Updated

December 17, 2018

Record last verified: 2018-12

Locations

SE(1)