Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-01-09 @ 3:57 PM
Study NCT ID:
NCT02520804
Status:
UNKNOWN
Last Update Posted:
2016-04-04
First Post:
2015-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Normal Saline Versus Balance Salt Solution Resuscitation on Kidney Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D012769', 'term': 'Shock'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C052337', 'term': 'sterofundin'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 107}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-31', 'studyFirstSubmitDate': '2015-07-29', 'studyFirstSubmitQcDate': '2015-08-09', 'lastUpdatePostDateStruct': {'date': '2016-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'acute kidney injury', 'timeFrame': '7 day', 'description': 'Number of Participants with acute kidney injury divided by KIDNEY DISEASE \\| IMPROVING GLOBAL OUTCOMES (KDIGO) Staging'}], 'secondaryOutcomes': [{'measure': 'Requirement of Renal replacement therapy (RRT)', 'timeFrame': 'up to 7 day'}, {'measure': 'sodium level', 'timeFrame': 'day 1-3', 'description': 'change from baseline'}, {'measure': 'potassium level', 'timeFrame': 'day 1-3', 'description': 'change from baseline'}, {'measure': 'chloride level', 'timeFrame': 'day 1-3', 'description': 'change from baseline'}, {'measure': 'bicarbonate level', 'timeFrame': 'day 1-3', 'description': 'change from baseline'}, {'measure': '28-day mortality', 'timeFrame': '28 days after admission', 'description': 'Number of Participants death within 28 day after admission'}, {'measure': 'ICU mortality', 'timeFrame': 'ICU admission up to 28 day', 'description': 'Number of Participants death at ICU within 28 day after admission'}, {'measure': 'hospital stay', 'timeFrame': 'during hospital admission up to 28 day', 'description': 'number of Hospital admission date'}, {'measure': 'ICU hospital stay', 'timeFrame': 'during admission up to 28 day', 'description': 'number of Hospital admission date'}, {'measure': 'mean arterial pressure', 'timeFrame': 'day1-3', 'description': 'mmHg (average)'}, {'measure': 'dose of norepinephrine', 'timeFrame': 'day1-3', 'description': '(µg/k/min)'}, {'measure': 'dose of adrenaline', 'timeFrame': 'day1-3', 'description': '(µg/k/min)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['balanced salt solution'], 'conditions': ['Acute Kidney Injury', 'Shock']}, 'referencesModule': {'references': [{'pmid': '8774792', 'type': 'BACKGROUND', 'citation': 'Barber AE, Shires GT. Cell damage after shock. New Horiz. 1996 May;4(2):161-7.'}, {'pmid': '7813251', 'type': 'BACKGROUND', 'citation': 'Kristensen SR. Mechanisms of cell damage and enzyme release. Dan Med Bull. 1994 Sep;41(4):423-33.'}, {'type': 'BACKGROUND', 'citation': 'Kumar A, Parrillo J. Shock: Classification,Pathophysiology, and Approach to Management. In: Dellinger R, Parillo J,eds. Critical Care Medicine: Principles of Diagnosis and Management in the Adult. Philadelphia: Mosby Elsevier,2008.'}, {'type': 'BACKGROUND', 'citation': "Marino PL.Inflammatory shock syndrome. In:Marino PL,eds. Marino's The ICU Book 4th edition.Philadelphia:Wolters Kluwer,2014."}, {'pmid': '24066745', 'type': 'BACKGROUND', 'citation': 'Myburgh JA, Mythen MG. Resuscitation fluids. N Engl J Med. 2013 Sep 26;369(13):1243-51. doi: 10.1056/NEJMra1208627. No abstract available.'}, {'pmid': '24330733', 'type': 'BACKGROUND', 'citation': "Martini WZ, Cortez DS, Dubick MA. Comparisons of normal saline and lactated Ringer's resuscitation on hemodynamics, metabolic responses, and coagulation in pigs after severe hemorrhagic shock. Scand J Trauma Resusc Emerg Med. 2013 Dec 11;21:86. doi: 10.1186/1757-7241-21-86."}, {'pmid': '22580944', 'type': 'BACKGROUND', 'citation': 'Chowdhury AH, Cox EF, Francis ST, Lobo DN. A randomized, controlled, double-blind crossover study on the effects of 2-L infusions of 0.9% saline and plasma-lyte(R) 148 on renal blood flow velocity and renal cortical tissue perfusion in healthy volunteers. Ann Surg. 2012 Jul;256(1):18-24. doi: 10.1097/SLA.0b013e318256be72.'}, {'pmid': '21067552', 'type': 'BACKGROUND', 'citation': 'Guidet B, Soni N, Della Rocca G, Kozek S, Vallet B, Annane D, James M. A balanced view of balanced solutions. Crit Care. 2010;14(5):325. doi: 10.1186/cc9230. Epub 2010 Oct 21.'}, {'pmid': '22738085', 'type': 'BACKGROUND', 'citation': "Perner A, Haase N, Guttormsen AB, Tenhunen J, Klemenzson G, Aneman A, Madsen KR, Moller MH, Elkjaer JM, Poulsen LM, Bendtsen A, Winding R, Steensen M, Berezowicz P, Soe-Jensen P, Bestle M, Strand K, Wiis J, White JO, Thornberg KJ, Quist L, Nielsen J, Andersen LH, Holst LB, Thormar K, Kjaeldgaard AL, Fabritius ML, Mondrup F, Pott FC, Moller TP, Winkel P, Wetterslev J; 6S Trial Group; Scandinavian Critical Care Trials Group. Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis. N Engl J Med. 2012 Jul 12;367(2):124-34. doi: 10.1056/NEJMoa1204242. Epub 2012 Jun 27."}, {'pmid': '19562988', 'type': 'BACKGROUND', 'citation': 'Ratanarat R, Hantaweepant C, Tangkawattanakul N, Permpikul C. The clinical outcome of acute kidney injury in critically ill Thai patients stratified with RIFLE classification. J Med Assoc Thai. 2009 Mar;92 Suppl 2:S61-7.'}, {'pmid': '23073953', 'type': 'BACKGROUND', 'citation': 'Yunos NM, Bellomo R, Hegarty C, Story D, Ho L, Bailey M. Association between a chloride-liberal vs chloride-restrictive intravenous fluid administration strategy and kidney injury in critically ill adults. JAMA. 2012 Oct 17;308(15):1566-72. doi: 10.1001/jama.2012.13356.'}, {'pmid': '22470070', 'type': 'BACKGROUND', 'citation': 'Shaw AD, Bagshaw SM, Goldstein SL, Scherer LA, Duan M, Schermer CR, Kellum JA. Major complications, mortality, and resource utilization after open abdominal surgery: 0.9% saline compared to Plasma-Lyte. Ann Surg. 2012 May;255(5):821-9. doi: 10.1097/SLA.0b013e31825074f5.'}, {'type': 'BACKGROUND', 'citation': 'Kidney disease: Improving Global outcomes (KDIGO) Acute kidney injury Work Group. KDIGO Clinical Practice Guideline for Acute Kidney injury.Kidney inter., Suppl.2012;2:1-138'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine Acute kidney injury incidence between sterofundin and normal saline ; Resuscitation shock patients', 'detailedDescription': 'Sample size:Compare proportion for independent two groups formula. n=sample size α risk of 0.05, Statistical power of 80% P1 =incidence of acute kidney injury (AKI) in control (0.6)\\* P2 =incidence of acute kidney injury (AKI) in balanced salt solution (0.4)\\*\\* from Ratanarat R,Hantaweepant C,Tangkawattanakul N,et al.The clinical outcome of acute kidney injury in critically ill Thai patients stratified with RIFLE classification.J Med Assoc Thai 2009 Mar;92 Suppl 2:61-7.\n\nα risk of 0.05, Statistical power of 80%\n\nSample size for interim analysis 1.11 x 97 = 107.67 total 108 (at least 50 cases each arm)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Shock patients (hypotension with signs of poor tissue perfusion)\n\nExclusion Criteria:\n\n* Age \\< 18 yr\n* Cardiogenic shock patients (History of ST elevation and Left ventricular ejection fraction (LVEF) \\< 35%),\n* Prolong shock \\>24 hrs,\n* Received chloride rich crystalloid (0.9% saline) or chloride rich colloid \\> 1000 ml within 72 hrs before recruitment\n* Do-not-resuscitation patients,\n* Contraindication for IV fluid administration such as pulmonary edema.,\n* Stage V chronic kidney disease (CKD),\n* chronic Hemodialysis or Peritonealdialyse'}, 'identificationModule': {'nctId': 'NCT02520804', 'briefTitle': 'Normal Saline Versus Balance Salt Solution Resuscitation on Kidney Function', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Effect of Normal Saline Versus Balance Salt Solution Resuscitation on Kidney Function; A Randomized Open Label Controlled Study', 'orgStudyIdInfo': {'id': 'Si566/2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'normal saline', 'description': 'normal saline for fluid resuscitation and maintenance for 72 hours', 'interventionNames': ['Drug: normal saline']}, {'type': 'EXPERIMENTAL', 'label': 'sterofundin', 'description': 'sterofundin for fluid resuscitation and maintenance for 72 hours', 'interventionNames': ['Drug: sterofundin']}], 'interventions': [{'name': 'sterofundin', 'type': 'DRUG', 'otherNames': ['balance salt solution'], 'description': 'sterofundin for shock patients in the first 72 hours', 'armGroupLabels': ['sterofundin']}, {'name': 'normal saline', 'type': 'DRUG', 'description': 'Normal saline for shock patients in the first 72 hours', 'armGroupLabels': ['normal saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'state': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Ranistha Rattanarat, MD', 'role': 'CONTACT', 'email': 'Ranittha@hotmail.com', 'phone': '0896685287'}], 'facility': 'Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Ranistha Ratanarat, MD', 'role': 'CONTACT', 'email': 'Ranittha@hotmail.com', 'phone': '66896685287'}], 'overallOfficials': [{'name': 'Ranistha Ratanarat, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mahidol University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}