Heart and Renal Failure in Hip Fracture Surgery

• Sponsor: Sahlgrenska University Hospital, Sweden (Other)
• Overall Status: Completed
• CT.gov ID: NCT03532919
• Collaborator: (none)
• Enrollment: 105
• Location: 1
• Actual Duration (Months): 10
• Patients Per Site Per Month: 10.5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hypotension; Hip Fractures; Renal Insufficiency; Heart Injuries	Diagnostic Test: Serum Tropinin

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

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 105 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Heart and Renal Failure in Hip Fracture Surgery
• Actual Study Start Date: Feb 1, 2018
• Actual Primary Completion Date: Aug 1, 2018
• Actual Study Completion Date: Dec 1, 2018

Outcome Measures

Primary Outcome Measures

1. Mortality [90 days]

   post surgery

Secondary Outcome Measures

1. Serum concentrations of Troponin, NTproBNP, Creatinin and Cystatin C [90 days]

   Relations between values and mortality at 30 and 90 days

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• Not forfilling inclusion Criterias

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sahlgrenska University Hospital	Molndal	Vastra Gotaland	Sweden	431 80

Sponsors and Collaborators

• Sahlgrenska University Hospital, Sweden

Investigators

• Principal Investigator: Bengt M Nellgard, MD PhD, SahlgrenskaUniversity Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bengt Nellgard, Associate professor, Sahlgrenska University Hospital, Sweden
• ClinicalTrials.gov Identifier: NCT03532919
• Other Study ID Numbers: Refhina
• First Posted: May 22, 2018
• Last Update Posted: Dec 17, 2018
• Last Verified: Dec 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Renal Insufficiency; Hypotension; Fractures, Bone; Hip Fractures; Heart Injuries; Cystatins

Study Results

No Results Posted as of Dec 17, 2018