Clinical trial NCT05349851: Bowel Cleansing With Renal Impairment
Official title: Clinical Registry of Adverse Effects in the Preparation for Colonoscopy in Patients With Advanced Renal Failure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Renal Impairment
Adverse Effects of Medical Drugs
Keywords: Colonoscopy
Bowel cleansing
Renal impairment
Hydroelectrolytic adverse effects
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
Collaborators: name: Complejo Hospitalario de Navarra
name: Althaia Xarxa Assistencial Universitària de Manresa
First posted: 2022-04-27
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients with a scheduled colonoscopy for any indication and with moderate or severe renal impairment

Brief summary: Bowel preparation for colonoscopy requires the administration of large amounts of fluids that can cause fluid and electrolyte disturbances and volume overload, especially in patients with advanced renal failure. Polyethylene glycol-based regimens are considered safe, even in patients with advanced renal failure. However, the incidence of adverse effects (AEs) in routine clinical practice is unknown. The main objective of this study is to carry out a prospective, observational, multicenter clinical registry of renal AE of the preparation for colonoscopy, in patients with advanced renal failure, within the usual clinical practice of the preparation. Variables related to kidney function, bowel-cleansing efficacy, and tolerance will also be recorded. A segmented analysis will be performed in patients with substitutive renal therapy (hemodialysis or peritoneal dialysis).

Detailed description: Introduction: Bowel preparation for colonoscopy requires the administration of large amounts of fluids that can cause fluid and electrolyte alterations and volume overload, especially in patients with advanced renal failure. Routine clinical practice of bowel preparation with polyethylene glycol-based regimens, including in patients with advanced renal failure, is considered safe. The hydroelectrolytic AEs and worsening of renal failure are generally mild and transient. However, the incidence of AEs in routine clinical practice is unknown, because there is no prospective record of the incidence of renal AEs in these patients.

Objectives:

1. Principal. To carry out a clinical registry of the renal AEs of the preparation for colonoscopy, in patients with advanced renal failure, within the usual clinical practice of the preparation.
2. Secondary:

   * Study the efficacy of intestinal cleansing using the Boston bowel preparation scale.
   * Study the patient-reported experience measures (PREMs) in terms of tolerability and acceptance of bowel preparation.

Study of the population and sample size: Outpatients with a scheduled colonoscopy for any indication and with moderate or severe renal impairment. Ages: 18-80, excluding partial colectomy, severe constipation, active intestinal disease, severe heart or liver failure, pregnancy or lactation, and refusal to authorize the clinical record of information. We calculated a sample size of 237 subjects to show an incidence of renal AD of 10%, with a precision of 4%.

Methods: Identify patients with a scheduled colonoscopy who present advanced renal failure, in the 60 days prior to the colonoscopy. Carry out a prospective, observational, multicenter clinical registry of the routine clinical practice of preparation for colonoscopy. Variables related to renal function, the efficacy of intestinal cleansing, and tolerance will be recorded. A segmented analysis will be performed in patients with substitutive renal therapy (hemodialysis or peritoneal dialysis). The data will be collected on the REDCap-AEG online platform, which can be accessed by researchers from each center through an identification code, respecting the current Organic Law on Data Protection.

Eligibility criteria: Inclusion Criteria:

* Outpatients or hospitalized patients with previously scheduled colonoscopy with any indication: screening, follow-up or symptoms.
* Diagnosis of stage 3B-5D chronic renal failure (creatinine clearance less than 45 ml / min / 1.73 m2).

Exclusion Criteria:

* Age less than 18 years or greater than 80 years
* Partial or total colectomy
* Severe constipation
* Active inflammatory bowel disease
* Severe hepatic impairment (Child Pugh Classification C)
* Pregnancy or breastfeeding
* Refusal to authorize the clinical registration of the information

Primary outcomes:
measure: Global incidence of renal adverse effects (AEs)
timeFrame: 3 hours to 7 days after laxative intake
Secondary outcomes:
measure: Serum sodium concentration
timeFrame: 3 hours to 7 days after laxative intake
measure: Serum potasium concentration
timeFrame: 3 hours to 7 days after laxative intake
measure: Serum ionized calcium concentration
timeFrame: 3 hours to 7 days after laxative intake
measure: Serum chloride concentration
timeFrame: 3 hours to 7 days after laxative intake
measure: Serum bicarbonate concentration
timeFrame: 3 hours to 7 days after laxative intake
measure: Serum creatinine concentration
timeFrame: 3 hours to 7 days after laxative intake
measure: Glomerular filtration rate
timeFrame: 3 hours to 7 days after laxative intake
measure: Serum phosphorus concentration
timeFrame: 3 hours to 7 days after laxative intake
measure: Serum magnesium concentration
timeFrame: 3 hours to 7 days after laxative intake
measure: Blood pH
timeFrame: 3 hours to 7 days after laxative intake
measure: Hemoglobin concentration
timeFrame: 3 hours to 7 days after laxative intake
measure: Blood platelets
timeFrame: 3 hours to 7 days after laxative intake
measure: Adequate bowel cleansing for colonoscopy
timeFrame: At the moment of colonoscopy
measure: Adhrence to laxative intake
timeFrame: 3-5 hours after laxative intake (at the colonoscopy appointment)
measure: Time from last intake of laxative to the colonoscopy
timeFrame: 3-5 hours after laxative intake (at the colonoscopy appointment)
measure: Patient-reported experience measures (PREMs) questionnaire of laxative intake
timeFrame: 3-5 hours after laxative intake (at the colonoscopy appointment)
measure: Early side effects of laxative intake
timeFrame: 3-5 hours after laxative intake (at the colonoscopy appointment)
measure: Late side effects of laxative intake
timeFrame: 3-7 days after laxative intake
measure: Need of urgent consultation
timeFrame: 3 hours to 7 days after laxative intake
measure: Need for hospital admission
timeFrame: 3 hours to 7 days after laxative intake
measure: Need of any drug treatment, new treatment or modification, that may affect kidney function or serum electrolytes
timeFrame: 3 hours to 7 days after laxative intake
Other outcomes:
Locations:
city: Manresa
country: Spain
facility: Althaia Xarxa Assistencial Universitària de Manresa
state: Cataluña
city: Tudela
country: Spain
facility: Hospital Reina Sofía
state: Navarra
Study officials:
affiliation: Althaia Xarxa Assistencial Universitària de Manresa; Institut Hospital del Mar d'investigacions mèdiques, Barcelona.
name: Marco A Álvarez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario de Navarra; Navarrabiomed; UPNA; IdiSNA
name: Eduardo Albéniz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: