NCT01868854

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2013

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 5, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

June 5, 2013

Status Verified

May 1, 2013

Enrollment Period

9 months

First QC Date

April 22, 2013

Last Update Submit

June 4, 2013

Conditions

Keywords

Tip catheterPeritoneal DialysisRisk FactotMecanical Function

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • LOCATION OF THE TIP OF PERITONEAL DIALYSIS CATHETER THROUGH STANDING ABDOMINAL RADIOGRAPHY

    12 HOURS AFTER CATHETER PLACEMENT, AND THE PATIENT WILL BE OBSERVED BY 1 WEEK

Other Outcomes (1)

  • DESCRIPTIVE VARIABLES

    PARTCIPANTS WILL BE FOLLOWED FOR THE DURATION OF HOSPITAL STAY, AND EXPECTED AVERAGE OF 2 WEEKS

Study Arms (4)

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

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • patients with agenesis of pelvic bones that prevent divisions radiographic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Franklin Mora, MD

    "José Carrasco Arteaga" Hospital, Cuenca-Ecuador.

    STUDY DIRECTOR
  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 22, 2013

First Posted

June 5, 2013

Study Start

March 1, 2013

Primary Completion

December 1, 2013

Study Completion

April 1, 2014

Last Updated

June 5, 2013

Record last verified: 2013-05