Risk Assessment of Peritoneal Dialysis Failure Based on Catheter Tip Location. (TIP-DP)

June 4, 2013 updated by: FRANKLIN MORA, Instituto Nacional de Cardiologia Ignacio Chavez

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

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

30

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

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic renal failure 5d: who are initiating peritoneal dialysis in any form

Description

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 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

Cohorts and Interventions

Group / Cohort
Radiographic Plane 1
the tip of peritoneal dialysis catheter is located at the bottom of the pelvis, below a line connecting the head of the femur
Radiographic Plane 2
the tip of the peritoneal dialysis catheter is located above the plane 1 and below a line connecting the two iliac spines
Radiographic plane 3
The location of the catheter tip is on the line connecting iliac spines and below a line connecting the iliac crests
Radiographic plane 4
The location of the catheter tip is on the line connecting the iliac crests

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MECHANICAL OPERATION OF PERITONEAL DIALYSIS CATHETER
Time Frame: TWELVE HOURS AFTER CATHETER PLACEMENT
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LOCATION OF THE TIP OF PERITONEAL DIALYSIS CATHETER THROUGH STANDING ABDOMINAL RADIOGRAPHY
Time Frame: 12 HOURS AFTER CATHETER PLACEMENT, AND THE PATIENT WILL BE OBSERVED BY 1 WEEK
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
DESCRIPTIVE VARIABLES
Time Frame: PARTCIPANTS WILL BE FOLLOWED FOR THE DURATION OF HOSPITAL STAY, AND EXPECTED AVERAGE OF 2 WEEKS
WEIGHT, SIZE, SEX, DIAGNOSIS, KT / V, AMONG OTHER
PARTCIPANTS WILL BE FOLLOWED FOR THE DURATION OF HOSPITAL STAY, AND EXPECTED AVERAGE OF 2 WEEKS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cardiologia Ignacio Chavez

Collaborators

JOSE CARRASCO ARTEAGA HOSPITAL FROM Ecuadorian Institute of Social Security
Hospital de Especialidades de las Fuerzas Armadas HE 1 QUITO

Investigators

  • Study Director: Franklin Mora, MD, "José Carrasco Arteaga" Hospital, Cuenca-Ecuador.
  • Principal Investigator: Jorge Huertas, MD, Hospital de Especialidades de las Fuerzas Armadas. Quito (Ecuador)
  • Principal Investigator: Magdalena Madero, MSC, "INSTITUTO NACIONAL IGNACIO CHAVEZ" México D.F.
  • Principal Investigator: Oscar Hernández, MD, "Instituto Nacional de Cardiología Ignacio Chávez".
  • Principal Investigator: Juan F Herrera, MD, Centro Médico ABC, Methodist International, Mexico D.F.
  • Principal Investigator: Alfonso Mariscal, MSC, Hospital Civil, Morelia Michoacán, México
  • Principal Investigator: Guadalupe De LA Cruz, RN, Hospital José Carrasco Arteaga, Cuenca-Ecuador

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

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

March 1, 2013

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

April 1, 2014

Study Registration Dates

First Submitted

April 22, 2013

First Submitted That Met QC Criteria

June 4, 2013

First Posted (Estimate)

June 5, 2013

Study Record Updates

Last Update Posted (Estimate)

June 5, 2013

Last Update Submitted That Met QC Criteria

June 4, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Incich-2013-Dp-0012

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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