Renal FailureTIP-DPNCT01868854
Risk Assessment of Peritoneal Dialysis Failure Based on Catheter Tip Location.
An observational study of Renal Failure, run by Instituto Nacional de Cardiologia Ignacio Chavez.
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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Renal Failure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Apr 2014
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with chronic renal failure 5d: who are initiating peritoneal dialysis in any form
Who may be able to join
- patients with functional class K-Digo 5d, initiating peritoneal dialysis program, with recent positioning of less than 2 weeks of dialysis catheter placement
Who cannot join
- patients with agenesis of pelvic bones that prevent divisions radiographic
About this study
Official title: 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.
Read the 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.
- Conditions
- Renal Failure
- Keywords
- Tip catheter, Peritoneal Dialysis, Risk Factot, Mecanical Function
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: TWELVE HOURS AFTER CATHETER PLACEMENT
Secondary outcomes (1)
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".
Measured: 12 HOURS AFTER CATHETER PLACEMENT, AND THE PATIENT WILL BE OBSERVED BY 1 WEEK
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2013 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
- Sponsor type
- University, hospital or other
- Collaborators
- JOSE CARRASCO ARTEAGA HOSPITAL FROM Ecuadorian Institute of Social Security, Hospital de Especialidades de las Fuerzas Armadas HE 1 QUITO
- Responsible party
- Principal investigator, FRANKLIN MORA, Instituto Nacional de Cardiologia Ignacio Chavez
- Investigators
- Franklin Mora, MD, Study director, "José Carrasco Arteaga" Hospital, Cuenca-Ecuador.Jorge Huertas, MD, Principal investigator, Hospital de Especialidades de las Fuerzas Armadas. Quito (Ecuador)Magdalena Madero, MSC, Principal investigator, "INSTITUTO NACIONAL IGNACIO CHAVEZ" México D.F.Oscar Hernández, MD, Principal investigator, "Instituto Nacional de Cardiología Ignacio Chávez".Juan F Herrera, MD, Principal investigator, Centro Médico ABC, Methodist International, Mexico D.F.Alfonso Mariscal, MSC, Principal investigator, Hospital Civil, Morelia Michoacán, MéxicoGuadalupe De LA Cruz, RN, Principal investigator, Hospital José Carrasco Arteaga, Cuenca-Ecuador
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868854
- Sponsor's protocol ID
- Incich-2013-Dp-0012
- Acronym
- TIP-DP
- Status last verified
- May 2013
- First submitted
- 22 Apr 2013
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
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 at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Assessment of Peritoneal Dialysis Failure Based on Catheter Tip Location. Multicentric Study.
- ClinicalTrials.gov ID
- NCT01868854
- Acronym / sponsor ID
- TIP-DP / Incich-2013-Dp-0012
- Conditions
- Renal Failure
- Keywords
- Tip catheter, Peritoneal Dialysis, Risk Factot, Mecanical Function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio ChavezUniversity, hospital or other
- Collaborators
- JOSE CARRASCO ARTEAGA HOSPITAL FROM Ecuadorian Institute of Social Security, Hospital de Especialidades de las Fuerzas Armadas HE 1 QUITO
- Study start
- Mar 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 5 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chronic renal failure 5d: who are initiating peritoneal dialysis in any form
Key inclusion criteria (1 listed)
- patients with functional class K-Digo 5d, initiating peritoneal dialysis program, with recent positioning of less than 2 weeks of dialysis catheter placement
Key exclusion criteria (1 listed)
- patients with agenesis of pelvic bones that prevent divisions radiographic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2013.
- BackgroundDe La Cruz G, Mora-Bravo F. Novel Classification to Monitor the Location of Peritoneal Dialysis Catheters. Blood Purif 35: 160-1, 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franklin Mora, MD study director
"José Carrasco Arteaga" Hospital, Cuenca-Ecuador.
Jorge Huertas, MD principal investigator
Hospital de Especialidades de las Fuerzas Armadas. Quito (Ecuador)
Magdalena Madero, MSC principal investigator
"INSTITUTO NACIONAL IGNACIO CHAVEZ" México D.F.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Failure, run by Instituto Nacional de Cardiologia Ignacio Chavez.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MECHANICAL OPERATION OF PERITONEAL DIALYSIS CATHETER (time frame: TWELVE HOURS AFTER CATHETER PLACEMENT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01868854, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2013.