Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-28 @ 2:11 PM
Study NCT ID:
NCT00885404
Status:
UNKNOWN
Last Update Posted:
2010-02-25
First Post:
2009-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chloride High Level Of Resuscitation Infusion Chloride High Level Of Resuscitation Infusion Delivered Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012769', 'term': 'Shock'}, {'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D000138', 'term': 'Acidosis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077325', 'term': "Ringer's Lactate"}, {'id': 'C048013', 'term': 'Plasmalyte A'}], '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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2010-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-02-24', 'studyFirstSubmitDate': '2009-04-21', 'studyFirstSubmitQcDate': '2009-04-21', 'lastUpdatePostDateStruct': {'date': '2010-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean base excess during hospital stay', 'timeFrame': 'Six month control period (before) and 6 month intervention period (after)'}], 'secondaryOutcomes': [{'measure': 'Unmeasured anions (strong ion gap) and chloride levels during hospital stay', 'timeFrame': 'Six month control period (before) and 6 month intervention period (after)'}, {'measure': 'Serum creatine levels', 'timeFrame': 'Six month control period (before) and 6 month intervention period (after)'}, {'measure': 'Length of ICU stay', 'timeFrame': 'Six month control period (before) and 6 month intervention period (after)'}, {'measure': 'Length of Emergency Department stay', 'timeFrame': 'Six month control period (before) and 6 month intervention period (after)'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Six month control period (before) and 6 month intervention period (after)'}, {'measure': 'In-hospital mortality', 'timeFrame': 'Six month control period (before) and 6 month intervention period (after)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chloride', 'acidosis'], 'conditions': ['Shock', 'Critical Illness']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Stewart PA. How to understand acid-base. A Quantitative Primer for Biology and Medicine. New York: Elsevier, 1981.'}, {'pmid': '6423247', 'type': 'BACKGROUND', 'citation': 'Stewart PA. Modern quantitative acid-base chemistry. Can J Physiol Pharmacol. 1983 Dec;61(12):1444-61. doi: 10.1139/y83-207.'}, {'pmid': '11939993', 'type': 'BACKGROUND', 'citation': "Sirker AA, Rhodes A, Grounds RM, Bennett ED. Acid-base physiology: the 'traditional' and the 'modern' approaches. Anaesthesia. 2002 Apr;57(4):348-56. doi: 10.1046/j.0003-2409.2001.02447.x."}, {'pmid': '12651634', 'type': 'BACKGROUND', 'citation': 'Constable PD. Hyperchloremic acidosis: the classic example of strong ion acidosis. Anesth Analg. 2003 Apr;96(4):919-922. doi: 10.1213/01.ANE.0000053256.77500.9D. No abstract available.'}, {'pmid': '9357917', 'type': 'BACKGROUND', 'citation': 'Dorje P, Adhikary G, McLaren ID, Bogush S. Dilutional acidosis or altered strong ion difference. Anesthesiology. 1997 Oct;87(4):1011-2; author reply 1013-4. doi: 10.1097/00000542-199710000-00052. No abstract available.'}, {'pmid': '10691256', 'type': 'BACKGROUND', 'citation': 'Story DA, Liskaser F, Bellomo R. Saline infusion, acidosis, and the Stewart approach. Anesthesiology. 2000 Feb;92(2):624; author reply 626. doi: 10.1097/00000542-200002000-00053. No abstract available.'}, {'pmid': '11412158', 'type': 'BACKGROUND', 'citation': 'Story DA, Poustie S, Bellomo R. Quantitative physical chemistry analysis of acid-base disorders in critically ill patients. Anaesthesia. 2001 Jun;56(6):530-3. doi: 10.1046/j.1365-2044.2001.01983.x.'}, {'pmid': '12519083', 'type': 'BACKGROUND', 'citation': "Reid F, Lobo DN, Williams RN, Rowlands BJ, Allison SP. (Ab)normal saline and physiological Hartmann's solution: a randomized double-blind crossover study. Clin Sci (Lond). 2003 Jan;104(1):17-24."}, {'pmid': '10691258', 'type': 'BACKGROUND', 'citation': 'Dorje P, Adhikary G, Tempe DK. Avoiding latrogenic hyperchloremic acidosis--call for a new crystalloid fluid. Anesthesiology. 2000 Feb;92(2):625-6. doi: 10.1097/00000542-200002000-00055. No abstract available.'}, {'pmid': '11902256', 'type': 'BACKGROUND', 'citation': 'Morgan TJ, Venkatesh B, Hall J. Crystalloid strong ion difference determines metabolic acid-base change during in vitro hemodilution. Crit Care Med. 2002 Jan;30(1):157-60. doi: 10.1097/00003246-200201000-00022.'}, {'pmid': '11889298', 'type': 'BACKGROUND', 'citation': 'Kellum JA. Fluid resuscitation and hyperchloremic acidosis in experimental sepsis: improved short-term survival and acid-base balance with Hextend compared with saline. Crit Care Med. 2002 Feb;30(2):300-5. doi: 10.1097/00003246-200202000-00006.'}, {'pmid': '14991093', 'type': 'BACKGROUND', 'citation': 'Morgan TJ, Venkatesh B, Hall J. Crystalloid strong ion difference determines metabolic acid-base change during acute normovolaemic haemodilution. Intensive Care Med. 2004 Jul;30(7):1432-7. doi: 10.1007/s00134-004-2176-x. Epub 2004 Feb 28.'}, {'pmid': '16790643', 'type': 'BACKGROUND', 'citation': 'Story DA, Morimatsu H, Bellomo R. Hyperchloremic acidosis in the critically ill: one of the strong-ion acidoses? Anesth Analg. 2006 Jul;103(1):144-8, table of contents. doi: 10.1213/01.ane.0000221449.67354.52.'}, {'pmid': '23073953', 'type': 'DERIVED', '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': '21705897', 'type': 'DERIVED', 'citation': 'Yunos NM, Kim IB, Bellomo R, Bailey M, Ho L, Story D, Gutteridge GA, Hart GK. The biochemical effects of restricting chloride-rich fluids in intensive care. Crit Care Med. 2011 Nov;39(11):2419-24. doi: 10.1097/CCM.0b013e31822571e5.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine whether intravenous fluid management using lower chloride solutions (Hartmann's solutions and Plasmalyte®) will result in better outcome when compared to management using high chloride solutions (0.9% saline and Gelofusine®).", 'detailedDescription': "This is a prospective, controlled, before-and-after study. The baseline pre-intervention period will include collection of data while doctors and nurses are unaware that such collection is taking place. During this time, high chloride fluids (saline, Gelofusine, 4% albumin) will continue to be used according to standard practice with an estimated 30,000 liters of saline as well as 2,000 bottles of Gelofusine® being consumed.\n\nFollowing a wash out period of education and preparation, there will be a complete shift to a working environment where use of saline, Gelofusine and any other fluids with a high chloride level (\\>110 mmol/L)will be restricted and substituted with fluids of lower chloride concentration similar to blood; either Hartmann's solution or Plasmalyte® or 20% albumin.\n\nThe study will compare a 6 month control period (before) and a six month intervention period (after)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All Intensive Care Unit (ICU) admissions at Austin Hospital\n* All Emergency Department (ED) admissions at Austin Hospital\n* All operations at Operating Theatre (OT) with hospital stay of more than 48 hours\n\nExclusion Criteria: Nil'}, 'identificationModule': {'nctId': 'NCT00885404', 'acronym': 'CHLORIDE', 'briefTitle': 'Chloride High Level Of Resuscitation Infusion Chloride High Level Of Resuscitation Infusion Delivered Evaluation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Austin Health'}, 'officialTitle': "A Prospective, Before and After Study of the Impact of Lower Chloride Intravenous Fluid Management on Patients' Acid-base Status, Renal Profile,Length of Stay and Mortality.", 'orgStudyIdInfo': {'id': '2008/03445'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intravenous fluids', 'interventionNames': ["Drug: Lower chloride fluids (Hartmann's solution and Plasmalyte®)"]}], 'interventions': [{'name': "Lower chloride fluids (Hartmann's solution and Plasmalyte®)", 'type': 'DRUG', 'otherNames': ['Plasmalyte', 'Lactated solution'], 'description': "Intravenous fluids used during the 6 month intervention period (after). Amount of fluids to be used is based on clinicians' discretion.", 'armGroupLabels': ['Intravenous fluids']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3084', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Austin Health', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': "Nor'azim Mohd Yunos, MBBS", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Intensive Care, Austin Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Austin Health', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': "Nor'azim Mohd Yunos", 'oldOrganization': 'Clinical Research Fellow, Department of Intensive Care, Austin Hospital.'}}}}