- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03795805
After Surgery Acute Renal Failure Incidence in Total Knee Arthroplasty With and Without Tourniquet
January 7, 2019 updated by: JUAN LOPEZ VALENCIA, Instituto Mexicano del Seguro Social
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
Study Overview
Status
Completed
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
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
-
-
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Ciudad de México, Mexico, 07020
- UMAE Dr. Victorio de La Fuente Narvaez
-
-
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
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: TKA and Tourniquet
Total knee arthroplasty and use of tourniquet limb cuff at 270 mmHg
|
Total knee arhroplasty
Other Names:
Tourniquet limb cuff and regular anesthesia
|
Experimental: Intraarticular lidocain
Total knee arthroplasty with Intaarticular lidocain
|
Total knee arhroplasty
Other Names:
20 ml of 2% lidocain application intraarticular before surgery (intraarticular lidocain)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Creatinin before surgery
Time Frame: Creatinin before surgery
|
Blood Creatinin meassure in mg/dl before surgery
|
Creatinin before surgery
|
Creatinin after surgery 1
Time Frame: Creatinin after surgery 1 at 24 hours
|
Blood Creatinin meassure in mg/dl at 24 hours
|
Creatinin after surgery 1 at 24 hours
|
Creatinin after surgery 2
Time Frame: Creatinin after surgery 2 at 48 hours
|
Blood Creatinin meassure in mg/dl at 48 hours
|
Creatinin after surgery 2 at 48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Avelino Colin Vázquez, MD, IMSS
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)
March 15, 2018
Primary Completion (Actual)
November 20, 2018
Study Completion (Actual)
December 20, 2018
Study Registration Dates
First Submitted
December 26, 2018
First Submitted That Met QC Criteria
January 7, 2019
First Posted (Actual)
January 8, 2019
Study Record Updates
Last Update Posted (Actual)
January 9, 2019
Last Update Submitted That Met QC Criteria
January 7, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Kidney Diseases
- Urologic Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Osteoarthritis
- Osteoarthritis, Knee
- Renal Insufficiency
- Acute Kidney Injury
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- R-2018-3401-053
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
We will share only de demographic data and trial results
Drug and device information, study documents
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
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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