Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2026-03-04 @ 12:22 AM
Study NCT ID:
NCT06541535
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-07
First Post:
2024-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluid Administration in Ketoacidosis (DRINK)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077325', 'term': "Ringer's Lactate"}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-02', 'studyFirstSubmitDate': '2024-07-08', 'studyFirstSubmitQcDate': '2024-08-02', 'lastUpdatePostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resolution of diabetic ketoacidosis', 'timeFrame': 'at 24 hours', 'description': 'Compare fluid resuscitaiton with Ringer Lactate to isotonic saline on the resolution of diabetic ketoacidosis at 24 hours from admission to Intensive Care Unit (ICU) in patients with severe diabetic ketoacidosis.\n\nResolution of ketoacidosis allowing discharge from ICU, defined as the proportion of patients with the following three criteria at 24 hours from ICU admission :\n\n1. capillary or blood glucose \\< 11 mmol/L\n2. undetectable ketonemia or ketonuria\n3. venous or arterial pH \\> 7.35 or venous or arterial bicarbonate \\> 20 mmol/L'}], 'secondaryOutcomes': [{'measure': 'Speed of resolution of metabolic disorders', 'timeFrame': 'at 48 hours', 'description': 'Compare fluid resuscitation with Ringer Lactate and isotonic saline solution on the speed of resolution of metabolic disorders in patients admitted to ICU for severe diabetic ketoacidosis.\n\nProportion of patients and number of hours ("Resolution free hours") within 48 hours of ICU admission with the following three criteria:\n\n1. capillary or blood glucose \\< 11 mmol/L\n2. undetectable ketonemia or ketonuria\n3. venous or arterial pH \\> 7.35 or venous or arterial bicarbonate \\> 20 mmol/L'}, {'measure': 'Time of resolution of metabolic disorders', 'timeFrame': 'at 48 hours', 'description': 'Compare fluid resuscitation with Ringer Lactate and isotonic saline solution on the speed of resolution of metabolic disorders in patients admitted to ICU for severe diabetic ketoacidosis.\n\nTime (in hours) from ICU admission to obtain one of the following three criteria:\n\n1. capillary or blood glucose \\< 11 mmol/L for at least 4 consecutive hours\n2. undetectable ketonemia or ketonuria\n3. venous or arterial pH \\> 7.35 or venous or arterial bicarbonate \\> 20 mmol/L'}, {'measure': 'Assess the metabolic tolerance of Ringer Lactate compared to isotonic saline solution', 'timeFrame': 'through the end of study average 24 months', 'description': 'Assess the metabolic tolerance of Ringer Lactate compared to isotonic saline solution in patients admitted to ICU for severe diabetic ketoacidosis.\n\nOccurrence of serious metabolic disorders during ICU stay, defined as :\n\n1. Kalemia \\< 3 mmol/L\n2. Natremia \\> 145 mmol/L\n3. Chloremia \\> 110 mmol/L\n4. Phosphoremia \\< 0.70 mmol/L\n5. Blood glucose \\< 3.8 mmol/L (i.e. 0.80 g/L)\n6. Persistent ketonemia/ketonuria 24 hours after ICU admission 2. Nature and volume (in liters) of fluid administered before inclusion and during the study period in each group 3. Protocol compliance (expressed as % of volume administered in each group)'}, {'measure': 'Assess the impact of Ringer lactate compared with isotonic saline on renal, neurological and cardiac complications', 'timeFrame': 'at 28 days', 'description': 'To assess the impact of Ringer lactate compared with isotonic saline on renal, neurological and cardiac complications during ICU stay and outcomes of patients admitted to ICU for severe diabetic ketoacidosis.\n\nOccurrence of adverse events during ICU stay, defined as :\n\n1. Neurological disorders (Glasgow score)\n2. Acute renal failure (KDIGO classification)\n3. Cardiac disorders (supraventricular and ventricular rhythm disorders, acute coronary syndrome) 2. ICU and hospital length of stay 3. ICU mortality and Day-28 mortality'}, {'measure': 'Assess the impact of Ringer lactate compared with isotonic saline on cardiac complications', 'timeFrame': 'at 28 days', 'description': 'To assess the impact of Ringer lactate compared with isotonic saline on cardiac complications during ICU stay and outcomes of patients admitted to ICU for severe diabetic ketoacidosis.\n\nOccurrence of adverse events during ICU stay, defined as :\n\n* Cardiac disorders (supraventricular and ventricular rhythm disorders, acute coronary syndrome)\n* ICU and hospital length of stay\n* ICU mortality and Day-28 mortality'}, {'measure': 'Assess the impact of Ringer lactate compared with isotonic saline on renal complications', 'timeFrame': 'at 28 days', 'description': 'To assess the impact of Ringer lactate compared with isotonic saline on renal, complications during ICU stay and outcomes of patients admitted to ICU for severe diabetic ketoacidosis.\n\nMeasure acute renal failure with KDIGO classification.\n\nThe Kidney Disease: Improving Global Outcomes (KDIGO) classification system stratifies acute kidney injury (AKI) into levels of severity, determined by changes in serum creatinine (SCr) / estimated creatinine clearance (eCCl), as well as changes in urine output. The strata of severity of AKI can be reached by meeting the criteria for changes in SCr / eCCl or changes in urine output. There are three levels of severity, with level 1 being the least severe and level 3 the most severe.\n\nNo cut-off for the study'}, {'measure': 'Assess the impact of Ringer lactate compared with isotonic saline on neurological complications', 'timeFrame': 'at 28 days', 'description': 'To assess the impact of Ringer lactate compared with isotonic saline on neurological complications during ICU stay and outcomes of patients admitted to ICU for severe diabetic ketoacidosis.\n\nMeasure Neurological disorders with Glasgow score. The Glasgow Coma Scale (GCS) is used to objectively describe the extent of impaired consciousness in all types of patients. The scale rates patients on three aspects of reactivity: eye opening, motor responses and verbal responses. It ranges from 3 (coma) to 15 (no disturbance of consciousness). No cut-off for the study.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Keto-acidosis']}, 'descriptionModule': {'briefSummary': 'Management of severe diabetic ketoacidosis is based on insulin therapy, correction of metabolic disorders and fluid resuscitation. Current recommendations recommend the first-line use of isotonic saline, whose composition is unbalanced, rich in chloride and sodium compared with plasma. Administration of large volumes of isotonic saline is associated with a risk of hyperchloremic metabolic acidosis and acute renal failure. Balanced solutions (e.g. Ringer Lactate) are solutions with a more balanced electrolyte composition close to that of plasma. They could therefore enable diabetic ketoacidosis to be resolved more quickly than isotonic saline, due to a lower risk of hyperchloremic acidosis. Preliminary data suggest a potential benefit of balanced solutions for fluid resuscitation of patients with severe diabetic ketoacidosis in terms of resolution of diabetic ketoacidosis, but no randomized controlled double-blind study to date has compared balanced solution vs. isotonic saline in this context.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admission to emergency department or direct admission to ICU\n* Diagnosis of severe diabetic ketoacidosis requiring all the following criteria:\n* Blood or capillary glucose \\> 11 mmol/L\n* Ketonemia or ketonuria \\> 0\n* Venous or arterial pH \\< 7.30 or venous or arterial bicarbonate \\< 15 mmol/L\n* Volume of fluid administered before inclusion \\<1L\n\nExclusion Criteria:\n\n* Patients \\<18 years\n* Pregnant women\n* Patients under protection\n* Patients with a decision to withdraw life-sustaining therapy\n* Contraindication to isotonic saline or Ringer Lactate\n* Non-affiliation to social security'}, 'identificationModule': {'nctId': 'NCT06541535', 'acronym': 'DRINK', 'briefTitle': 'Fluid Administration in Ketoacidosis (DRINK)', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Comparison of Saline and Ringer Lactate in Patients With Severe Diabetic Ketoacidosis (DRINK) : a Double-blind Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '22-API-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Isotonic saline', 'interventionNames': ['Drug: Fluid resuscitation with isotonic saline only']}, {'type': 'EXPERIMENTAL', 'label': 'Ringer Lactate', 'interventionNames': ['Drug: Fluid resuscitation with Ringer Lactate']}], 'interventions': [{'name': 'Fluid resuscitation with isotonic saline only', 'type': 'DRUG', 'description': 'Isotonic saline only will be used for fluid resuscitation in the first 48 hours of treatment, according to the protocol of English guidelines:\n\n* During the first hour of treatment:\n\n * In the event of systolic arterial hypotension (SAP\\<90mmHg): administration of 500 mL over 15 minutes, renewable once, then administration of 1L over 1 hour.\n * In the absence of systolic arterial hypotension (SAP\\>90mmHg): administration of 1L over 1 hour.\n* Between 60 minutes and 8 hours of treatment :\n\n * 1L over 2 hours, repeated once, then 1L over 4 hours\n * Adjust fluid resuscitation according to clinical tolerance\n* After the first 8 hours:\n\n * 1L over 4h then 1L over 6h\n * Clinical re-evaluation according to standard of care in participating centers', 'armGroupLabels': ['Isotonic saline']}, {'name': 'Fluid resuscitation with Ringer Lactate', 'type': 'DRUG', 'description': 'Ringer Lactate only will be used for fluid resuscitation in the first 48 hours of treatment, according to the protocol of English guidelines:\n\n* During the first hour of treatment:\n\n * In the event of systolic arterial hypotension (SAP\\<90mmHg): administration of 500 mL over 15 minutes, renewable once, then administration of 1L over 1 hour.\n * In the absence of systolic arterial hypotension (SAP\\>90mmHg): administration of 1L over 1 hour.\n* Between 60 minutes and 8 hours of treatment :\n\n * 1L over 2 hours, repeated once, then 1L over 4 hours\n * Adjust fluid resuscitation according to clinical tolerance\n* After the first 8 hours:\n\n * 1L over 4h then 1L over 6h\n * Clinical re-evaluation according to standard of care in participating centers', 'armGroupLabels': ['Ringer Lactate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nice', 'country': 'France', 'contacts': [{'name': 'MATHIEU JOZWIAK, MD PhD', 'role': 'CONTACT', 'email': 'jozwiak.m@chu-nice.fr', 'phone': '+33492035510'}], 'facility': 'CHU NICE', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'centralContacts': [{'name': 'Mathieu JOZWIAK, MD PhD', 'role': 'CONTACT', 'email': 'jozwiak.m@chu-nice.fr', 'phone': '+33492035510'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}