Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-03-07 @ 5:17 PM
Study NCT ID:
NCT04102527
Status:
UNKNOWN
Last Update Posted:
2022-09-08
First Post:
2019-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Impact of Transit Troubles in Patients Undergoing Peritoneal Dialysis
Sponsor:
Centre Hospitalier de Vichy
Organization:
Study Overview
Official Title:
Evaluation of the Impact of Transit Troubles in Patients Undergoing Peritoneal
Status:
UNKNOWN
Status Verified Date:
2022-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TransDiPe
Brief Summary:
Patients with Terminal Chronic Kidney Disease undergoing Peritoneal Dialysis (PD) often have pathophysiological factors that promote chronic constipation. It affects the quality of life of Patients undergoing PD in a much greater way than for hemodialysis patients because it causes complications, mechanical and infectious associated with the transmural migration of enteral bacteria, with an impact on patient morbidity and survival of the technique. In addition, it should be noted that PD patients often take potentially constipants treatments such as phosphorus chelators, calcium inhibitors, opiates, iron preparation and antidepressants. Taking these drugs decreases gastric acidity, which is associated with an increased prevalence of peritonitis.
In this context, a significant lack of literature, specifically studying the risk factors for constipation in Terminal Chronic Kidney Disease patients treated with DP and the correlation with mechanical and infectious complications, is improvable.
In this context, a significant lack of literature, specifically studying the risk factors for constipation in Terminal Chronic Kidney Disease patients treated with DP and the correlation with mechanical and infectious complications, is improvable.
Detailed Description:
Patients included in this trial will be monitored as part of the usual management of their pathology, a Terminal Chronic Kidney Disease treated by the Peritoneal Dialysis technique.
During this treatment, patients will be follow every 2 months in consultation in the Metabolic Diseases Department of the Hospital of Vichy.
These consultations include:
* Pre-selection consultation/Inclusion (visit to J0 -3 months)
* Half-yearly review (visit J0, visit at 12 months and visit at 24 months)
* Simple consultation (visits to 2, 4, 8, 10, 14, 16, 20, 22 months)
* Annual review (visits at 6 and 18 months)
In this prospective trial, there is no intervention on the patient; They will only have to complete questionnaires on their intestinal transit (Charlson Scale, Katz Scale, Neurological Functional Score, Intestinal Function Index, Severity Score for constipation, Bristol Scale, Constipation Assessment Scale, Constipation Risk Assessment Scale). No minimal risk and constraint is identified, excluding our trial from the category of interventional research. The category 3 (non-interventional trial) of the jardé classification is therefore accepted.
During this treatment, patients will be follow every 2 months in consultation in the Metabolic Diseases Department of the Hospital of Vichy.
These consultations include:
* Pre-selection consultation/Inclusion (visit to J0 -3 months)
* Half-yearly review (visit J0, visit at 12 months and visit at 24 months)
* Simple consultation (visits to 2, 4, 8, 10, 14, 16, 20, 22 months)
* Annual review (visits at 6 and 18 months)
In this prospective trial, there is no intervention on the patient; They will only have to complete questionnaires on their intestinal transit (Charlson Scale, Katz Scale, Neurological Functional Score, Intestinal Function Index, Severity Score for constipation, Bristol Scale, Constipation Assessment Scale, Constipation Risk Assessment Scale). No minimal risk and constraint is identified, excluding our trial from the category of interventional research. The category 3 (non-interventional trial) of the jardé classification is therefore accepted.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: