Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2026-03-23 @ 7:27 PM
Study NCT ID:
NCT02067195
Status:
UNKNOWN
Last Update Posted:
2015-08-21
First Post:
2014-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aggressive hydraTion in Patients With ST -Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention to prevenT Contrast-Induced Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 560}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-08-20', 'studyFirstSubmitDate': '2014-02-16', 'studyFirstSubmitQcDate': '2014-02-19', 'lastUpdatePostDateStruct': {'date': '2015-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Contrast-Induced Nephropathy', 'timeFrame': '72 hours', 'description': 'defined as a greater than 25% or an absolute increase of 0.5 mg/dl in serum creatinine over baseline during the first 48- 72 h post-procedure'}, {'measure': 'Contrast Induced Acute Kidney Injury', 'timeFrame': '24 hours', 'description': 'defined as a greater than 10% or an absolute increase of 0.3mg/dl in serum Cystatin C over baseline during the first 24 h post-procedure.'}], 'secondaryOutcomes': [{'measure': 'contrast-induced acute kidney injury', 'timeFrame': '48 hours', 'description': 'defined as a greater than 50% or an absolute increase of 0.3 mg/dl in serum creatinine over baseline during the first 48h post-procedure'}, {'measure': 'Composite contrast-induced acute kidney injury', 'timeFrame': '48 hours', 'description': 'Defined as an absolute increase of 0.3 mg/dl in serum creatinine over baseline during the first 48h post-procedure and as a greater than 10% in Cystatin C over baseline during the first 24h post-procedure'}, {'measure': 'Persistent renal damage', 'timeFrame': '3 months', 'description': 'Defined as a residual impairment of renal function indicated by a reduction of creatinine clearance more than 25% at 3 months in comparison with baseline'}, {'measure': 'Alteration of renal function', 'timeFrame': '72 hours', 'description': 'defined as the alteration of creatinine clearance and estimated glomerular filtration rate (GFR) by using Cystatin C over baseline during the first 48- 72 h post-procedure'}, {'measure': 'Severe adverse renal events', 'timeFrame': '1 year', 'description': 'Including contrast-induced nephropathy requiring renal replacement therapy and death caused by contrast-induced nephropathy'}, {'measure': 'Major adverse cardiovascular events', 'timeFrame': '1 year', 'description': 'Major adverse cardiovascular events included death, re- current myocardial infarction, repeated urgent revascularization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acute myocardial infarction,contrast,coronary intervention'], 'conditions': ['ST Elevation Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '32580757', 'type': 'DERIVED', 'citation': 'Guo W, Song F, Chen S, Zhang L, Sun G, Liu J, Chen J, Liu Y, Tan N; RESCIND group. The relationship between hyperuricemia and contrast-induced acute kidney injury undergoing primary percutaneous coronary intervention: secondary analysis protocol for the ATTEMPT RESCIND-1 study. Trials. 2020 Jun 24;21(1):567. doi: 10.1186/s13063-020-04505-w.'}, {'pmid': '32395501', 'type': 'DERIVED', 'citation': 'Liu J, Guo Z, Lei L, Sun G, He Y, Song F, Chen J, Tan N, Chen S, Liu Y. Statistical analysis plan for aggressive hydraTion in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention to prevenT contrast-induced nephropathy (ATTEMPT) study. Ann Transl Med. 2020 Apr;8(7):457. doi: 10.21037/atm.2020.03.192.'}, {'pmid': '31133052', 'type': 'DERIVED', 'citation': 'Song F, Sun G, Liu J, Chen JY, He Y, Liu L, Liu Y; RESCIND group. Efficacy of post-procedural oral hydration volume on risk of contrast-induced acute kidney injury following primary percutaneous coronary intervention: study protocol for a randomized controlled trial. Trials. 2019 May 27;20(1):290. doi: 10.1186/s13063-019-3413-5.'}, {'pmid': '26856220', 'type': 'DERIVED', 'citation': 'Liu Y, Chen JY, Huo Y, Ge JB, Xian Y, Duan CY, Chen SQ, Jiang W, Chen PY, Tan N; RESCIND group. Aggressive hydraTion in patients with ST-Elevation Myocardial infarction undergoing Primary percutaneous coronary intervention to prevenT contrast-induced nephropathy (ATTEMPT): Study design and protocol for the randomized, controlled trial, the ATTEMPT, RESCIND 1 (First study for REduction of contraSt-induCed nephropathy followINg carDiac catheterization) trial. Am Heart J. 2016 Feb;172:88-95. doi: 10.1016/j.ahj.2015.10.007. Epub 2015 Oct 20.'}]}, 'descriptionModule': {'briefSummary': 'To compare the efficacy of 2 different hydration strategies, hydration according to clinical guideline and adequate hydration, on contrast-induced nephropathy in patients with STEMI undergoing primary PCI to investigate the possible beneficial role of periprocedural adequate hydration.', 'detailedDescription': 'all consecutive patients with STEMI，age at least 18 years, who were candidates for primary PCI at our institution were considered for enrollment in the present study. Initial exclusion criteria were contrast medium administration within the previous 14 days, end-stage renal failure requiring dialysis, and refusal to give informed consent. Eligible patients were randomly assigned in a 1:1 ratio to receive preprocedure and postprocedure hydration (adequate hydration group), hydration according to clinical guideline (guideline hydration group，control group )'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all consecutive patients with STEMI, age at least 18 years, who were candidates for primary PCI were considered for enrollment.\n\nExclusion Criteria:\n\n* contrast medium administration within the previous 14 days or follow 72 hours,\n* end-stage renal failure or renal transplantation, and refuse PCI or dead during the procedure,\n* heart failure of cardiac shock or New York Heart Association class IV,\n* recent acute kidney injury defined as an absolute increase of 0.5 mg/dl in serum creatinine over baseline in the past 24h\n* ,the presence of lactation, pregnancy,\n* malignant tumour or life expectancy less than 1 year,\n* allergy to contrast, peri-procedural receipt of metformin non-steroidalanti-inflammatory drugs in the past 48h and during the study period,\n* planned renal catheterization or heart valvular surgery。'}, 'identificationModule': {'nctId': 'NCT02067195', 'acronym': 'ATTEMPT', 'briefTitle': 'Aggressive hydraTion in Patients With ST -Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention to prevenT Contrast-Induced Nephropathy', 'organization': {'class': 'OTHER', 'fullName': "Guangdong Provincial People's Hospital"}, 'officialTitle': 'Aggressive Hydration in Patients With ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention to Prevent Contrast-Induced Nephropathy, A Randomized, Controlled Trial REduction of riSk of Contrast-Induced Nephropathy followINg carDiac Catheterization 1', 'orgStudyIdInfo': {'id': 'CSC20140222'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Guideline Hydration', 'description': 'No hydration for patients without chronic kidney disease(CrCl\\<60ml/min),or Receiving hydration with a 1 mL/kg bolus of intravenous isotonic saline (0.9% sodium chloride) after diagnosis of chronic kidney disease until 24 hours after PCI. Hydration rate was reduced to 0.5 mL/kg per hour in patients with New York Heart Association class III or KillipⅡ/Ⅲ.', 'interventionNames': ['Drug: Receiving hydration with a 1 mL/kg bolus of intravenous isotonic saline (0.9% sodium chloride)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Adequate Hydration', 'description': 'Receiving hydration with a 3 mL/kg.hour bolus of intravenous isotonic saline (0.9% sodium chloride) from randomization to the end of the procedure, the measurement of LVEDP was conducted after the procedure, a sliding-scale hydration was employed in the LVEDP-guided hydration arm that was based on LVEDP for 2 hours: 5 ml/kg/hr for LVEDP \\<13 mmHg, 3 ml/kg/hr for LVEDP 13-18 mmHg, and \\>1.5 ml/kg/hr for LVEDP \\>18 mmHg, whereas,0.5 ml/kg/hr for LVEDP \\>20 mmHg, continue hydration with a 1 mL/kg until 24 hours after procedure. Hydration rate was reduced to 0.5 mL/kg per hour in patients with New York Heart Association class III or KillipⅡ/Ⅲ.', 'interventionNames': ['Drug: 3 mL/kg.hour bolus of intravenous isotonic saline (0.9% sodium chloride)']}], 'interventions': [{'name': 'Receiving hydration with a 1 mL/kg bolus of intravenous isotonic saline (0.9% sodium chloride)', 'type': 'DRUG', 'otherNames': ['Guideline Hydration'], 'description': 'No hydration for patients without chronic kidney disease(CrCl\\<60ml/min),or Receiving hydration with a 1 mL/kg bolus of intravenous isotonic saline (0.9% sodium chloride) after diagnosis of chronic kidney disease until 24 hours after PCI. Hydration rate was reduced to 0.5 mL/kg per hour in patients with New York Heart Association class III or KillipⅡ/Ⅲ.', 'armGroupLabels': ['Guideline Hydration']}, {'name': '3 mL/kg.hour bolus of intravenous isotonic saline (0.9% sodium chloride)', 'type': 'DRUG', 'otherNames': ['Adequate Hydration'], 'description': 'Receiving hydration with a 3 mL/kg.hour bolus of intravenous isotonic saline (0.9% sodium chloride) from randomization to the end of the procedure, the measurement of LVEDP was conducted after the procedure, a sliding-scale hydration was employed in the LVEDP-guided hydration arm that was based on LVEDP for 2 hours: 5 ml/kg/hr for LVEDP \\<13 mmHg, 3 ml/kg/hr for LVEDP 13-18 mmHg, and \\>1.5 ml/kg/hr for LVEDP \\>18 mmHg, whereas,0.5 ml/kg/hr for LVEDP \\>20 mmHg, continue hydration with a 1 mL/kg until 24 hours after procedure. Hydration rate was reduced to 0.5 mL/kg per hour in patients with New York Heart Association class III or KillipⅡ/Ⅲ.', 'armGroupLabels': ['Adequate Hydration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '501080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yong Liu, MD', 'role': 'CONTACT', 'email': 'liuyong2099@126.com', 'phone': '86-20-83827812', 'phoneExt': '10528'}, {'name': 'Yuanhui Liu, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hualong Li, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Guangdong General Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Jiyan Chen, MD', 'role': 'CONTACT', 'email': 'chenjiyandr@126.com', 'phone': '86-20-83827812', 'phoneExt': '10528'}], 'overallOfficials': [{'name': 'Jiyan Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Guangdong Cardiovascular Institute,Guangdong General Hospital'}, {'name': 'Yong Liu, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Guangdong Cardiovascular Institute,Guangdong General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking University First Hospital', 'class': 'OTHER'}, {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, {'name': 'Fudan University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Jiyan Chen', 'investigatorAffiliation': "Guangdong Provincial People's Hospital"}}}}