Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2025-12-28 @ 2:25 AM
Study NCT ID:
NCT00199706
Status:
COMPLETED
Last Update Posted:
2011-07-01
First Post:
2005-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HyperHAES Versus Placebo - Effect on Intracranial Pressure in SAH Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D019586', 'term': 'Intracranial Hypertension'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-11', 'completionDateStruct': {'date': '2004-10'}, 'lastUpdateSubmitDate': '2011-06-30', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-14', 'lastUpdatePostDateStruct': {'date': '2011-07-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in intracranial pressure (ICP) measured as area under the curve (AUC) during the 210 minutes trial period'}], 'secondaryOutcomes': [{'measure': 'Changes in cerebral perfusion pressure (CPP) measured as AUC'}, {'measure': 'changes in cardiac output'}, {'measure': 'intrathorasic blood volume'}, {'measure': 'extravascular lung water'}, {'measure': 'serum sodium levels during the 210 minutes trial period'}]}, 'conditionsModule': {'keywords': ['Intracranial Pressure', 'Intracranial Hypertension', 'Hypertonic Solutions', 'Saline Solutions, Hypertonic'], 'conditions': ['Subarachnoid Hemorrhage']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether 7.2% NaCl in 6% hydroxyethyl starch will lower intracranial pressure (ICP) in SAH-patients with normal or moderately elevated ICP in a placebo controlled study, and to describe the haemodynamic effects.', 'detailedDescription': 'In the acute phase after a SAH, many patients need intensive care treatment to control the development of fatally increased intracranial pressure. One type of treatment used is osmotherapy. Traditionally mannitol has been the preferred drug, but the use of hypertonic saline solutions has gained more and more acceptance. The immediate effect seems to be equivalent or better than with mannitol, and there seem to be less adverse effects, such as hypovolemia, acute renal failure, hyponatremia, and rebound increase of ICP.\n\nMost clinical studies in patients with life-threatening increase in ICP are observational, and show a predictable effect of hypertonic saline. We wanted to strengthen our own findings from such a study by applying the same study model but with a placebo control group in patients with only moderately elevated ICP.\n\nWe also wanted to document the haemodynamic effects, measuring cardiac output, intrathorasic blood volume and extravascular lung water.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Subarachnoid Hemorrhage, source of bleeding radiologically or surgically secured\n* Age \\> 18 years\n* Mechanically ventilated\n* Sedated\n* Stable hemodynamics\n* Stable intracranial pressure between 10 - 20 mmHg\n\nExclusion criteria:\n\n\\- Serum sodium \\> 160 mmol/l'}, 'identificationModule': {'nctId': 'NCT00199706', 'briefTitle': 'HyperHAES Versus Placebo - Effect on Intracranial Pressure in SAH Patients', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': '7.2% NaCl in 6% Hydroxyethyl Starch Versus Placebo - Effect on Intracranial Pressure and Haemodynamics in Subarachnoidal Haemorrhage (SAH) Patients.', 'orgStudyIdInfo': {'id': '2002-SAHA'}, 'secondaryIdInfos': [{'id': 'S-01264'}]}, 'armsInterventionsModule': {'interventions': [{'name': '7.2% NaCl in 6% hydroxyethyl starch solution', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gunnar Bentsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}}}}