Risk Assessment of Peritoneal Dialysis Failure Based on Catheter Tip Location.

Renal Failure Clinical Trial

— TIP-DP  

Official title:

Risk Assessment of Peritoneal Dialysis Failure Based on Catheter Tip Location. Multicentric Study.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01868854
• Other study ID #: Incich-2013-Dp-0012
• Status: Enrolling by invitation
• Phase: N/A
• First received: April 22, 2013
• Last updated: June 4, 2013
• Start date: March 2013
• Est. completion date: April 2014

Study information

• Verified date: May 2013
• Source: Instituto Nacional de Cardiologia Ignacio Chavez
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Instituto Mexicano De Investigaciones Nefrológicas.Ecuador: Ethical Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: April 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Renal Failure

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Instituto Nacional de Cardiologia Ignacio Chavez	Hospital de Especialidades de las Fuerzas Armadas HE 1 QUITO, JOSE CARRASCO ARTEAGA HOSPITAL FROM Ecuadorian Institute of Social Security

References & Publications (1)

De La Cruz G, Mora-Bravo F. Novel Classification to Monitor the Location of Peritoneal Dialysis Catheters. Blood Purif 35: 160-1, 2013.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	DESCRIPTIVE VARIABLES	WEIGHT, SIZE, SEX, DIAGNOSIS, KT / V, AMONG OTHER	PARTCIPANTS WILL BE FOLLOWED FOR THE DURATION OF HOSPITAL STAY, AND EXPECTED AVERAGE OF 2 WEEKS	No
Primary	MECHANICAL OPERATION OF PERITONEAL DIALYSIS CATHETER	MEASURE THE TIME THAT RETURNING IN 1 LITER OF SOLUTION AFTER INFUSION PERITONEAL. TAKE IT AS FLUID RETURN FAILURE WHEN A DELAY SAME OR GREATER THAN 20 MINUTES.	TWELVE HOURS AFTER CATHETER PLACEMENT	No
Secondary	LOCATION OF THE TIP OF PERITONEAL DIALYSIS CATHETER THROUGH STANDING ABDOMINAL RADIOGRAPHY	RADIOGRAPIC PLANS ARE CLASSIFIED IN 4 LEVEL: 1) BELOW THE "HEADS OF THE FEMUR", 2) BELOW " ILIAC SPINES", 3) BELOW THE "ILIAC CREST", 4) ABOVE "THE ILIAC CREST".	12 HOURS AFTER CATHETER PLACEMENT, AND THE PATIENT WILL BE OBSERVED BY 1 WEEK	No