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

Conditions

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

  • Mexico
      • 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
Procedure: total knee arthroplasty
Total knee arhroplasty
Other Names:
  • TKA
Procedure: Tourniquet limb cuff
Tourniquet limb cuff and regular anesthesia
Experimental: Intraarticular lidocain
Total knee arthroplasty with Intaarticular lidocain
Procedure: total knee arthroplasty
Total knee arhroplasty
Other Names:
  • TKA
Drug: Intaarticular lidocain
20 ml of 2% lidocain application intraarticular before surgery (intraarticular lidocain)
Other Names:
  • lidocaine

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.

Sponsor

Instituto Mexicano del Seguro Social

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

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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