After Surgery Acute Renal Failure Incidence in Total Knee Arthroplasty With and Without Tourniquet

Knee Osteoarthritis Clinical Trial

Official title:

After Surgery Acute Renal Failure Incidence in Total Knee Arthroplasty With and Without Tourniquet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03795805
• Other study ID #: R-2018-3401-053
• Status: Completed
• Phase: N/A
• Start date: March 15, 2018
• Est. completion date: December 20, 2018

Study information

• Verified date: January 2019
• Source: Instituto Mexicano del Seguro Social
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 20, 2018
• Est. primary completion date: November 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Arthroplasty, Replacement, Knee
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Renal Insufficiency
• Tourniquets

Intervention

Procedure:
• total knee arthroplasty
Total knee arhroplasty
• Tourniquet limb cuff
Tourniquet limb cuff and regular anesthesia

Drug:
• Intaarticular lidocain
20 ml of 2% lidocain application intraarticular before surgery (intraarticular lidocain)

Locations

Country	Name	City	State
Mexico	UMAE Dr. Victorio de La Fuente Narvaez	Ciudad de México

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Mexicano del Seguro Social

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Creatinin before surgery	Blood Creatinin meassure in mg/dl before surgery	Creatinin before surgery
Primary	Creatinin after surgery 1	Blood Creatinin meassure in mg/dl at 24 hours	Creatinin after surgery 1 at 24 hours
Primary	Creatinin after surgery 2	Blood Creatinin meassure in mg/dl at 48 hours	Creatinin after surgery 2 at 48 hours