Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-04-04 @ 3:39 PM
Study NCT ID:
NCT01670604
Status:
UNKNOWN
Last Update Posted:
2012-08-22
First Post:
2012-08-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Two Modern Hydroxyethyl Starch Solutions in Major Urological Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006895', 'term': 'Hydroxyethyl Starch Derivatives'}, {'id': 'C485123', 'term': 'HES 130-0.4'}], 'ancestors': [{'id': 'D013213', 'term': 'Starch'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'lastUpdateSubmitDate': '2012-08-20', 'studyFirstSubmitDate': '2012-08-05', 'studyFirstSubmitQcDate': '2012-08-20', 'lastUpdatePostDateStruct': {'date': '2012-08-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative volume replacement therapy', 'timeFrame': 'From randomization, for the duration of surgery and up to transfer from the operating room to the ICU or recovery room, an expected average of 6 hours', 'description': 'volume of the study drug in milliliters that will be needed for hemodynamic stabilization until the end of surgery (ie, the cumulative volume of the study drug in milliliters administered up to this time point).'}], 'secondaryOutcomes': [{'measure': 'Acid base and Renal function', 'timeFrame': '24 hours after randomization', 'description': 'differences in the plasma creatinine concentrations and acid-base homeostasis among the study groups'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Urologic Surgical Procedures']}, 'referencesModule': {'references': [{'pmid': '18813', 'type': 'BACKGROUND', 'citation': 'Kluft C, Jenks RL, Astrup T. Production of plasminogen actovatpr activity in factor XII-deficient plasma. Thromb Res. 1977 May;10(5):759-64. doi: 10.1016/0049-3848(77)90058-5. No abstract available.'}, {'pmid': '18633', 'type': 'BACKGROUND', 'citation': 'Takayanagi I, Maruyama M, Takagi K. Beta-adrenoceptors in the guinea pig treated with egg-albumin. Jpn J Pharmacol. 1977 Apr;27(2):314-6. doi: 10.1254/jjp.27.314. No abstract available.'}, {'pmid': '10319', 'type': 'BACKGROUND', 'citation': 'Mitchell AR, Erickson BW, Ryabtsev MN, Hodges RS, Merrifield RB. Tert-butoxycarbonylaminoacyl-4-(oxymethyl)-phenylacetamidomethyl-resin, a more acid-resistant support for solid-phase peptide synthesis. J Am Chem Soc. 1976 Nov 10;98(23):7357-62. doi: 10.1021/ja00439a041. No abstract available.'}, {'pmid': '21345', 'type': 'BACKGROUND', 'citation': "Birke ER. [On the action of antihypotensive agents in sympathicotonic orthostatic hypotension in geriartric patients: comparison between placebo and etilefrin (author's transl)]. Med Klin. 1977 Oct 14;72(41):1696-702. German."}]}, 'descriptionModule': {'briefSummary': 'This study compares the effect of infusion of two types of modern hydroxyethyl starch on the renal function and acid-base in patients undergoing urologic surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age group above 18 years,\n* ASA І and ІІ,\n* Patients who will be scheduled to undergo radical prostatectomy or cystectomy with bladder replacement\n\nExclusion Criteria:\n\n* A known allergy to HES,\n* Renal insufficiency (serum creatinine of \\>2.5 mg/dL),\n* Significant hepatic disease (liver function tests more than three times the upper limit of normal),\n* Coagulation disorders (INR \\> 1.5).'}, 'identificationModule': {'nctId': 'NCT01670604', 'briefTitle': 'Use of Two Modern Hydroxyethyl Starch Solutions in Major Urological Procedures', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'The Use of Two Modern Hydroxyethyl Starch Solutions in Major Urological Procedures: Effect on Acid-Base Status and Renal Functions', 'orgStudyIdInfo': {'id': 'KAH012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VOL group', 'description': 'patients will receive 6% HES 130/0.4 in NaCl 0.9% (Voluven, Fresenius Kabi, Bad Hom-bourg, Germany)', 'interventionNames': ['Drug: 6% HES 130/0.4 in NaCl 0.9% (Voluven, Fresenius Kabi, Bad Hom-bourg, Germany)']}, {'type': 'EXPERIMENTAL', 'label': 'TET group', 'description': 'patient will receive 6% HES 130/0.42 in a balanced electrolyte containing Na+140 mmol/L, Cl- 118 mmol/L, K +4 mmol/L, Ca++ 2.5 mmol/L, Mg++ 1 mmol/L, acetate- 24 mmol/L and malate-- 5 mmol/L', 'interventionNames': ['Drug: Tetraspan, B. Braun, Melsungen, Germany']}], 'interventions': [{'name': '6% HES 130/0.4 in NaCl 0.9% (Voluven, Fresenius Kabi, Bad Hom-bourg, Germany)', 'type': 'DRUG', 'armGroupLabels': ['VOL group']}, {'name': 'Tetraspan, B. Braun, Melsungen, Germany', 'type': 'DRUG', 'armGroupLabels': ['TET group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11559', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Amr Hussein, MSc', 'role': 'CONTACT', 'email': 'amrhussein1981@hotmail.com', 'phone': '01069338998', 'phoneExt': '+2'}, {'name': 'Abeer Ahmed, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nazmy Seif, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ahmed Helmy, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ahmed Mukhtar, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Amr Hussein, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kasralainy Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Amr Hussein, MSc', 'role': 'CONTACT', 'email': 'amrhussein1981@hotmail.com', 'phone': '01069338998', 'phoneExt': '+2'}, {'name': 'Ahmed Mukhtar, MD', 'role': 'CONTACT', 'email': 'Ahmed.Mukhtar@kasralainy.edu.eg', 'phone': '01114208444', 'phoneExt': '+2'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of anesthesia Cairo University', 'investigatorFullName': 'Ahmed Mukhtar', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}