Clinical trial NCT01868854: Risk Assessment of Peritoneal Dialysis Failure Based on Catheter Tip Location.
Official title: Risk Assessment of Peritoneal Dialysis Failure Based on Catheter Tip Location. Multicentric Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Renal Failure
Keywords: Tip catheter
Peritoneal Dialysis
Risk Factot
Mecanical Function
Lead sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
Sponsor class: OTHER
Collaborators: name: JOSE CARRASCO ARTEAGA HOSPITAL FROM Ecuadorian Institute of Social Security
name: Hospital de Especialidades de las Fuerzas Armadas HE 1 QUITO
First posted: 2013-06-05
Enrollment: 30
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic renal failure 5d: who are initiating peritoneal dialysis in any form

Brief summary: The location of the catheter tip in radiographic planes 1 and 2, is a protection factor for the mechanical performance of peritoneal Dialysis. Instead radiographic planes 3 and 4 are risk factors.

Detailed description: Radiolucency of the peritoneal dialysis catheter, allow to classify the location of the tip into 4 radiographic planes. Plane 1: below the zone of a line on the head of the femur. Plane 2: is the area above the plane 1 and below a line connecting the two iliac spines. Plane 3: is the area that is above the plane 2 and below a line connecting the upper edge of the two iliac crests. Plane 4: is the area located above the plane 3.

Eligibility criteria: Inclusion Criteria:

* patients with functional class K-Digo 5d, initiating peritoneal dialysis program, with recent positioning of less than 2 weeks of dialysis catheter placement

Exclusion Criteria:

* patients with agenesis of pelvic bones that prevent divisions radiographic

Primary outcomes:
measure: MECHANICAL OPERATION OF PERITONEAL DIALYSIS CATHETER
timeFrame: TWELVE HOURS AFTER CATHETER PLACEMENT
Secondary outcomes:
measure: LOCATION OF THE TIP OF PERITONEAL DIALYSIS CATHETER THROUGH STANDING ABDOMINAL RADIOGRAPHY
timeFrame: 12 HOURS AFTER CATHETER PLACEMENT, AND THE PATIENT WILL BE OBSERVED BY 1 WEEK
Other outcomes:
measure: DESCRIPTIVE VARIABLES
timeFrame: PARTCIPANTS WILL BE FOLLOWED FOR THE DURATION OF HOSPITAL STAY, AND EXPECTED AVERAGE OF 2 WEEKS
Locations:
Study officials:
affiliation: "José Carrasco Arteaga" Hospital, Cuenca-Ecuador.
name: Franklin Mora, MD
role: STUDY_DIRECTOR
affiliation: Hospital de Especialidades de las Fuerzas Armadas. Quito (Ecuador)
name: Jorge Huertas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: "INSTITUTO NACIONAL IGNACIO CHAVEZ" México D.F.
name: Magdalena Madero, MSC
role: PRINCIPAL_INVESTIGATOR
affiliation: "Instituto Nacional de Cardiología Ignacio Chávez".
name: Oscar Hernández, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Médico ABC, Methodist International, Mexico D.F.
name: Juan F Herrera, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Civil, Morelia Michoacán, México
name: Alfonso Mariscal, MSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital José Carrasco Arteaga, Cuenca-Ecuador
name: Guadalupe De LA Cruz, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: De La Cruz G, Mora-Bravo F. Novel Classification to Monitor the Location of Peritoneal Dialysis Catheters. Blood Purif 35: 160-1, 2013.