Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:33 PM
Study NCT ID:
NCT05349851
Status:
UNKNOWN
Last Update Posted:
2023-11-18
First Post:
2022-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bowel Cleansing With Renal Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D016482', 'term': 'Urinalysis'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D003950', 'term': 'Diagnostic Techniques, Urological'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 237}, 'targetDuration': '7 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-16', 'studyFirstSubmitDate': '2022-03-31', 'studyFirstSubmitQcDate': '2022-04-22', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global incidence of renal adverse effects (AEs)', 'timeFrame': '3 hours to 7 days after laxative intake', 'description': 'Global incidence of renal adverse effects (AEs) (yes/no) if any of the following variables have an abnormal value in serum: sodium, potassium, calcium, chloride, bicarbonate, creatinine, or the glomerular filtrate rate calculated with the MDRD formula and the CKD-EPI formula.'}], 'secondaryOutcomes': [{'measure': 'Serum sodium concentration', 'timeFrame': '3 hours to 7 days after laxative intake', 'description': 'Any abnormal value in serum sodium concentration.'}, {'measure': 'Serum potasium concentration', 'timeFrame': '3 hours to 7 days after laxative intake', 'description': 'Any abnormal value in serum potasium concentration.'}, {'measure': 'Serum ionized calcium concentration', 'timeFrame': '3 hours to 7 days after laxative intake', 'description': 'Any abnormal value in serum ionized calcium concentration.'}, {'measure': 'Serum chloride concentration', 'timeFrame': '3 hours to 7 days after laxative intake', 'description': 'Any abnormal value in serum chloride concentration.'}, {'measure': 'Serum bicarbonate concentration', 'timeFrame': '3 hours to 7 days after laxative intake', 'description': 'Any abnormal value in serum bicarbonate concentration.'}, {'measure': 'Serum creatinine concentration', 'timeFrame': '3 hours to 7 days after laxative intake', 'description': 'Any abnormal value in serum creatinine concentration.'}, {'measure': 'Glomerular filtration rate', 'timeFrame': '3 hours to 7 days after laxative intake', 'description': 'Glomerular filtration rate calculated with the MDRD formula and the CKD-EPI formula.'}, {'measure': 'Serum phosphorus concentration', 'timeFrame': '3 hours to 7 days after laxative intake', 'description': 'Any abnormal value in serum phosphorus concentration.'}, {'measure': 'Serum magnesium concentration', 'timeFrame': '3 hours to 7 days after laxative intake', 'description': 'Any abnormal value in serum magnesium concentration.'}, {'measure': 'Blood pH', 'timeFrame': '3 hours to 7 days after laxative intake', 'description': 'Blood pH measurement'}, {'measure': 'Hemoglobin concentration', 'timeFrame': '3 hours to 7 days after laxative intake', 'description': 'Mean corpuscular hemoglobin'}, {'measure': 'Blood platelets', 'timeFrame': '3 hours to 7 days after laxative intake', 'description': 'Number of blood platelets'}, {'measure': 'Adequate bowel cleansing for colonoscopy', 'timeFrame': 'At the moment of colonoscopy', 'description': 'Application of the Boston Bowel Preparation Scale to evaluate colonoscopy bowel cleansing. The efficacy of bowel preparation will be rated by blinded endoscopists using the Boston Bowel Preparation Scale (BBPS). Adequate bowel cleansing will be defined as a BBPS of 2 or more points in every segment of the colon and inadequate bowel cleansing will be defined by at least one of the colon segments with less than 2 points.'}, {'measure': 'Adhrence to laxative intake', 'timeFrame': '3-5 hours after laxative intake (at the colonoscopy appointment)', 'description': 'Adhrence to laxative intake recorded as \\>75% of the quantity of laxative intake reported in a questionarie administered with the help of an investigator.'}, {'measure': 'Time from last intake of laxative to the colonoscopy', 'timeFrame': '3-5 hours after laxative intake (at the colonoscopy appointment)', 'description': 'Interval in hours between last intake of laxative and the colonoscopy.'}, {'measure': 'Patient-reported experience measures (PREMs) questionnaire of laxative intake', 'timeFrame': '3-5 hours after laxative intake (at the colonoscopy appointment)', 'description': 'Patient-reported experience measures (PREMs) questionnaire of laxative intake, administered with the help of an investigator. Descriptive subjective scale: Very bad, bad, average, good, very Good.'}, {'measure': 'Early side effects of laxative intake', 'timeFrame': '3-5 hours after laxative intake (at the colonoscopy appointment)', 'description': 'Early side effects of laxative intake. Structured questionnaire nausea, vomiting, dizziness, thirst, headache, abdominal bloating. Non structured for other side effects.'}, {'measure': 'Late side effects of laxative intake', 'timeFrame': '3-7 days after laxative intake', 'description': 'Structured questionnaire nausea, vomiting, dizziness, thirst, headache, abdominal bloating, abdominal pain, mental confusion, asthenia, dyspnea, peripheral edema. Non structured for other side effects.'}, {'measure': 'Need of urgent consultation', 'timeFrame': '3 hours to 7 days after laxative intake', 'description': 'Number of participants requiring medical consultation for kidney related problems, including emergency room or nephrologist consultation.'}, {'measure': 'Need for hospital admission', 'timeFrame': '3 hours to 7 days after laxative intake', 'description': 'Number of participants requiring hospital admission for any kidney related causes.'}, {'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', 'description': 'Number of participants that require outpatient medication change after the intervention.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colonoscopy', 'Bowel cleansing', 'Renal impairment', 'Hydroelectrolytic adverse effects'], 'conditions': ['Renal Impairment', 'Adverse Effects of Medical Drugs']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.\n\nObjectives:\n\n1. 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.\n2. Secondary:\n\n * Study the efficacy of intestinal cleansing using the Boston bowel preparation scale.\n * Study the patient-reported experience measures (PREMs) in terms of tolerability and acceptance of bowel preparation.\n\nStudy 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%.\n\nMethods: 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatients with a scheduled colonoscopy for any indication and with moderate or severe renal impairment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatients or hospitalized patients with previously scheduled colonoscopy with any indication: screening, follow-up or symptoms.\n* Diagnosis of stage 3B-5D chronic renal failure (creatinine clearance less than 45 ml / min / 1.73 m2).\n\nExclusion Criteria:\n\n* Age less than 18 years or greater than 80 years\n* Partial or total colectomy\n* Severe constipation\n* Active inflammatory bowel disease\n* Severe hepatic impairment (Child Pugh Classification C)\n* Pregnancy or breastfeeding\n* Refusal to authorize the clinical registration of the information'}, 'identificationModule': {'nctId': 'NCT05349851', 'acronym': 'BC-RIMP', 'briefTitle': 'Bowel Cleansing With Renal Impairment', 'organization': {'class': 'OTHER', 'fullName': 'Parc de Salut Mar'}, 'officialTitle': 'Clinical Registry of Adverse Effects in the Preparation for Colonoscopy in Patients With Advanced Renal Failure', 'orgStudyIdInfo': {'id': '2020/9515'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Renal failure patiens', 'description': 'Patients with advanced renal failure', 'interventionNames': ['Other: Follow-up with blood and urine analysis']}], 'interventions': [{'name': 'Follow-up with blood and urine analysis', 'type': 'OTHER', 'description': 'The patients will receive the preparation standards according to the usual clinical practice of each center. On the day of the colonoscopy, patient will be informed about this study and the informed consent will be requested to record the study information. Then, an analysis will be carried out. A second visit will be carried out, follow-up at 3-7 days, which will include a clinical interview and an analysis, being the unique intervention that patients receive.', 'armGroupLabels': ['Renal failure patiens']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08243', 'city': 'Manresa', 'state': 'Catalonia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Raúl Velamazán, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Althaia Xarxa Assistencial Universitària de Manresa', 'geoPoint': {'lat': 41.72815, 'lon': 1.82399}}, {'city': 'Tudela', 'state': 'Navarre', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Diego Martínez, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Reina Sofía', 'geoPoint': {'lat': 42.06166, 'lon': -1.60452}}], 'centralContacts': [{'name': 'Marco A Álvarez, MD, PhD', 'role': 'CONTACT', 'email': 'maalvarez@althaia.cat', 'phone': '0034 933160595'}, {'name': 'Eduardo Albéniz, MD, PhD', 'role': 'CONTACT', 'email': 'ealbenia@navarra.es', 'phone': '0034 848420370'}], 'overallOfficials': [{'name': 'Marco A Álvarez, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Althaia Xarxa Assistencial Universitària de Manresa; Institut Hospital del Mar d'investigacions mèdiques, Barcelona."}, {'name': 'Eduardo Albéniz, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario de Navarra; Navarrabiomed; UPNA; IdiSNA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marco Antonio Alvarez Gonzalez', 'class': 'OTHER'}, 'collaborators': [{'name': 'Complejo Hospitalario de Navarra', 'class': 'OTHER'}, {'name': 'Althaia Xarxa Assistencial Universitària de Manresa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Marco Antonio Alvarez Gonzalez', 'investigatorAffiliation': 'Parc de Salut Mar'}}}}