Back to resultsAfter Surgery Acute Renal Failure Incidence in Total Knee Arthroplasty With and Without Tourniquet
Primary Purpose
Arthroplasty, Replacement, Knee, Acute Kidney Injury, Tourniquets
Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
total knee arthroplasty
Tourniquet limb cuff
Intaarticular lidocain
Sponsored by
About this trial
This is an interventional prevention trial for Arthroplasty, Replacement, Knee
Eligibility Criteria
Inclusion Criteria:
- Patients knee arthrosis
- Required a surgical treatment with Total Knee Arthroplasty
Exclusion Criteria:
- Not accept to be in the study
- Not signed consent form
- Not having blood sample for creatinin meassure
Sites / Locations
- UMAE Dr. Victorio de La Fuente Narvaez
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
TKA and Tourniquet
Intraarticular lidocain
Arm Description
Total knee arthroplasty and use of tourniquet limb cuff at 270 mmHg
Total knee arthroplasty with Intaarticular lidocain
Outcomes
Primary Outcome Measures
Creatinin before surgery
Blood Creatinin meassure in mg/dl before surgery
Creatinin after surgery 1
Blood Creatinin meassure in mg/dl at 24 hours
Creatinin after surgery 2
Blood Creatinin meassure in mg/dl at 48 hours
Secondary Outcome Measures
Full Information
NCT ID
NCT03795805
First Posted
December 26, 2018
Last Updated
January 7, 2019
Sponsor
Instituto Mexicano del Seguro Social
1. Study Identification
Unique Protocol Identification Number
NCT03795805
Brief Title
After Surgery Acute Renal Failure Incidence in Total Knee Arthroplasty With and Without Tourniquet
Official Title
After Surgery Acute Renal Failure Incidence in Total Knee Arthroplasty With and Without Tourniquet
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
November 20, 2018 (Actual)
Study Completion Date
December 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Mexicano del Seguro Social
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study analize the incidence of acute renal failure after performing total knee arthroplasty with or without use of tourniquet limb cuff (half of patients for each group) in a randomized clinical trial
Detailed Description
This study analize the incidence of acute renal failure after performing total knee arthroplasty with or without (using local intraarticular anesthesia) use of tourniquet limb cuff (half of patients for each group) in a randomized clinical trial
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthroplasty, Replacement, Knee, Acute Kidney Injury, Tourniquets, Knee Osteoarthritis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Clinical Trial
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TKA and Tourniquet
Arm Type
Other
Arm Description
Total knee arthroplasty and use of tourniquet limb cuff at 270 mmHg
Arm Title
Intraarticular lidocain
Arm Type
Experimental
Arm Description
Total knee arthroplasty with Intaarticular lidocain
Intervention Type
Procedure
Intervention Name(s)
total knee arthroplasty
Other Intervention Name(s)
TKA
Intervention Description
Total knee arhroplasty
Intervention Type
Procedure
Intervention Name(s)
Tourniquet limb cuff
Intervention Description
Tourniquet limb cuff and regular anesthesia
Intervention Type
Drug
Intervention Name(s)
Intaarticular lidocain
Other Intervention Name(s)
lidocaine
Intervention Description
20 ml of 2% lidocain application intraarticular before surgery (intraarticular lidocain)
Primary Outcome Measure Information:
Title
Creatinin before surgery
Description
Blood Creatinin meassure in mg/dl before surgery
Time Frame
Creatinin before surgery
Title
Creatinin after surgery 1
Description
Blood Creatinin meassure in mg/dl at 24 hours
Time Frame
Creatinin after surgery 1 at 24 hours
Title
Creatinin after surgery 2
Description
Blood Creatinin meassure in mg/dl at 48 hours
Time Frame
Creatinin after surgery 2 at 48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients knee arthrosis
Required a surgical treatment with Total Knee Arthroplasty
Exclusion Criteria:
Not accept to be in the study
Not signed consent form
Not having blood sample for creatinin meassure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avelino Colin Vázquez, MD
Organizational Affiliation
IMSS
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMAE Dr. Victorio de La Fuente Narvaez
City
Ciudad de México
ZIP/Postal Code
07020
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We will share only de demographic data and trial results
Learn more about this trial
After Surgery Acute Renal Failure Incidence in Total Knee Arthroplasty With and Without Tourniquet
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