Evaluation of the Impact of Transit Troubles in Patients Undergoing Peritoneal Dialysis

NCT04102527 | Unknown

• 1 other identifier: CHV 2018-1
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Peritoneal Dialysis Complication; Constipation

Outcome Measures

Primary Outcomes (1)

• To determine whether there is a relationship between transit disorders and the rate of digestive germ peritonitis in patients with Terminal Chronic Kidney disease on Peritoneal Dialysis

  The investigators will count the number of peritonitis associated with transit disorders in patients with Terminal Chronic Kidney Disease undergoing Peritoneal Dialysis

  4 years

Secondary Outcomes (1)

• To determine whether there are variations in the relationship between transit disorders and the rate of peritonitis depending on the therapeutic management of these transit disorders.

  4 years

Study Arms (1)

Patients

Patients with Terminal Chronic Kidney Disease undergoing Peritoneal Dialysis for at least three months in stable condition

Other: Questionnaires

Interventions

Questionnaires OTHER

Patients have to complete the study questionnaires every 2 months : * Digestive Functional Score of Neurological Patients * Bowel Function Index * Severity score for constipation * Bristol Scale * Constipation assessment scale * Estimate scale of risk of constipation

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Clinically stable patients who have been in Peritoneal Dialysis for at least three months will be pre-selected three months before the start of the study and included via the Metabolic diseases Center of the Hospital. This protocol will be offered to adult patients suffering from Terminal Chronic Kidney disease undergoing Peritoneal Dialysis. The investigator will inform the details of the protocol and answer all questions from patients. It will be given sufficient time to reflect for the signing of the information and non-opposition form. Volunteers will be included after signing this document.

You may qualify if:

• Patients with TerminalChronic Kidney disease undergoing Peritoneal Dialysis for at least three months in stable condition,
• Patients who are able to complete the study questionnaires every 2 months,
• Cooperation and understanding sufficient to comply with the requirements of the study,
• Ability to understand the French language for an informed understanding of the information and non-opposition forms,
• Affiliation with the French Social Security scheme.

You may not qualify if:

• Patients whose peritoneal dialysis catheter is considered non-functional at J0,
• Patients with a medical and/or surgical history considered by the investigator or his representative to be not compatible with the trial,
• Patients who are mentally incapacitated to answer questionnaires,
• Women of childbearing age who do not use an effective contraceptive method, pregnant or lactating women.
• Patients with legal protection measures (curatorship, guardianship, etc.).

Sponsors & Collaborators

• Centre Hospitalier de Vichy: lead
• University Hospital, Clermont-Ferrand: collaborator

Study Sites (1)

Hospital center

Vichy, 03200, France

RECRUITING

MeSH Terms

Conditions

Constipation

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Delphine ROUX

CONTACT

0033470971314; delphine.roux@ch-vichy.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 25, 2019
• Study Start: December 19, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: September 8, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)