Volulyte
Trials 31
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 38 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT02906514 | Dec 2016 → Aug 2017 | — | Hospices Civils de Lyon | Completed | No outcome recorded |
| Phase 3 | NCT02192502 | Mar 2015 → Feb 2018 | acute kidney injury | The Cleveland Clinic | Completed | No outcome recorded |
| Phase 3 | NCT02584868 | Feb 2013 → Nov 2016 | — | Queen Fabiola Children's University Hospital | Completed | Missed primary |
| Phase 3 | NCT01127477 | May → Dec 2010 | — | Fresenius Kabi Japan | Completed | No outcome recorded |
| Phase 3 | NCT00962156 | Dec 2009 → Mar 2012 | infectious disease with sepsis | Anders Perner | Completed | No outcome recorded |
| Phase 3 | NCT01010022 | Nov 2009 → Jul 2010 | hemorrhagic disease | Fresenius Kabi Japan | Completed | No outcome recorded |
| Phase 3 | NCT01758172 | Oct 2009 → Oct 2010 | — | Asan Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT00464204 | Jul 2007 → May 2010 | infectious disease with sepsis | Fresenius Kabi | Completed | Met primary |
| Phase 416 trials · 2 met primary · 1 missed | ||||||
| Phase 4 | NCT06663254 | Nov 2024 → Mar 2026 overdue | — | Xiangya Hospital of Central South University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT03338218 | Feb 2019 → Jun 2022 | acute hypotension | Fresenius Kabi | Completed | No outcome recorded |
| Phase 4 | NCT03420261 | Aug 2017 → Jul 2018 | — | University Hospital, Clermont-Ferrand | Completed | No outcome recorded |
| Phase 4 | NCT02312999 | Feb 2015 → Dec 2017 | — | Brugmann University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01689506 | Dec 2012 → Sep 2013 | — | Fresenius Kabi | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01553617 | Oct 2012 → Jan 2014 | postoperative ventricular dysfunction | Fresenius Kabi | Completed | No outcome recorded |
| Phase 4 | NCT01670604 | Jan 2012 → Mar 2013 | — | Kasr El Aini Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01415284 | Oct 2011 → Jun 2013 | hypotensive disorder | Maisonneuve-Rosemont Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01303250 | Apr 2011 → Apr 2015 | — | University Hospital Muenster | Terminated | No outcome recorded |
| Phase 4 | NCT00936247 | Nov 2009 → Sep 2010 | impaired renal function disease | B. Braun Melsungen AG | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01012648 | Nov 2009 → Jan 2013 | — | University of Zurich | Unknown | Missed primary |
| Phase 4 | NCT01051206 | May 2009 → Feb 2010 | coronary artery disorder | Yonsei University | Completed | No outcome recorded |
| Phase 4 | NCT00431743 | Apr → Sep 2009 | — | Rigshospitalet, Denmark | Unknown | No outcome recorded |
| Phase 4 | NCT00860405 | Mar 2009 → Aug 2010 | cardiac valvular defect | Fresenius Kabi | Completed | Met primary |
| Phase 4 | NCT00694343 | Jun 2008 → Dec 2009 | hypotensive disorder | Fresenius Kabi | Completed | Met primary |
| Phase 4 | NCT00308100 | Oct 2005 → Jul 2008 | — | Fresenius Kabi | Terminated | No outcome recorded Stop: Enrollment |
| Phase not applicable7 trials · 1 missed | ||||||
| — | NCT07329660 | Feb → Dec 2026 expected | — | Air Force Military Medical University, China | Not yet recruiting | No outcome recorded |
| — | NCT05475886 | Feb → Apr 2024 | — | General Hospital of Ningxia Medical University | Unknown | No outcome recorded |
| — | NCT05728645 | Jul 2023 → Mar 2025 | — | Xijing Hospital | Completed | No outcome recorded |
| — | NCT03252496 | Aug 2017 → Jul 2021 | preeclampsia | Mansoura University | Completed | No outcome recorded |
| — | NCT02961842 | Nov 2016 → Mar 2017 | — | Mansoura University | Completed | Missed primary |
| — | NCT01195025 | Aug 2010 → May 2011 | blood coagulation disease | University Hospital, Linkoeping | Completed | No outcome recorded |
| — | NCT00978588 | Feb → Dec 2008 | mitral valve disorder | Yonsei University | Completed | No outcome recorded |
| Comparator or background therapy12 trials | ||||||
| Phase 3 | NCT01301469 Comparator | Feb → Jul 2011 | hypotensive disorder | B. Braun Melsungen AG | Completed | No outcome recorded |
| Phase 3 | NCT00799916 Comparator | Jan 2006 → Aug 2009 | infectious disease with sepsis | National University of La Plata | Completed | No outcome recorded |
| Phase 4 | NCT01882075 Comparator | Jun 2013 → Dec 2014 | — | Hopital Foch | Terminated | No outcome recorded |
| Phase 4 | NCT02587078 Comparator | Mar → Jun 2013 | infectious disease with sepsis | Wuerzburg University Hospital | Withdrawn | No outcome recorded |
| Phase 4 | NCT01444508 Comparator | Sep 2011 → Apr 2013 | — | K. C. Rasmussen | Unknown | No outcome recorded |
| Phase 4 | NCT00576849 Comparator | Dec 2007 → May 2010 | — | Klinikum Ludwigshafen | Completed | No outcome recorded |
| — | NCT05435573 Comparator | Aug 2022 → Sep 2023 | — | Mansoura University | Completed | No outcome recorded |
| — | NCT01874730 Background | Jul 2013 → Jun 2015 | — | Duke University | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT01512628 Comparator | Jan 2012 → Dec 2013 | avascular necrosis | Seoul National University Bundang Hospital | Completed | No outcome recorded |
| — | NCT01882920 Background | Jun 2010 → Jun 2012 | peritoneal neoplasm | Regina Elena Cancer Institute | Completed | No outcome recorded |
| — | NCT00964015 Comparator | Aug 2009 → Jun 2010 | — | London Health Sciences Centre | Terminated | No outcome recorded Stop: Business |
| — | NCT01644084 Comparator | Jun 2009 → Jan 2011 | — | Yonsei University | Completed | No outcome recorded |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 47 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Volulyte | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01689506 ↗ |
| Known as | HES 130/0.4 | “HES 130/0.4 significantly solution will not affect on coagulation and blood loss in patients medicated with antiplatelet agents prior to off-pump coronary bypass surgery (OPCAB).” NCT01051206 ↗10“This study evaluated whether administration of hydroxyethyl starch (HES) 130/0.4 affects coagulation competence and influences the perioperative blood loss.” PMID 24100337 ↗ Feb 2014 “Patients with severe sepsis were randomized for EGDT with 6% HES 130/0.4 (n = 9) or SS (n = 11).” PMID 20813485 ↗ Sep 2010 “Volulyte® (6% HES 130/0.4 in balanced solution)” NCT01874730 ↗ |
| Known as | HES 130/0.4 (6%) | “This study will compare the clinical efficacy and safety of HES 130/0.4 (6%) in normal saline vs. Ringer's lactate solution in prevention of hypotension during spinal...” NCT00694343 ↗ |
| Known as | HES 130/0.42 | “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...” NCT01670604 ↗ |
| Known as | hydroxyethyl starch | “This study evaluated whether administration of hydroxyethyl starch (HES) 130/0.4 affects coagulation competence and influences the perioperative blood loss.” PMID 24100337 ↗ Feb 2014 |
| Known as | hydroxyethyl starch 130 | “60 g/l hydroxyethyl starch 130 dissolved in plasma adapted Ringer's solution (balanced solution)” NCT01301469 ↗ |
| Known as | Hydroxyethyl starch 130/0,4 (HES 130,04) | “Hydroxyethyl starch 130/0,4 (HES 130,04)” NCT01882920 ↗ |
| Known as | hydroxyethyl starch 130/0.4 | “6% Hydroxyethyl starch (130/0.4) vs Ringer's lactate preloading before spinal anaesthesia for Caesarean delivery: the randomized, double-blind, multicentre CAESAR trial.” PMID 24970272 ↗ Jun 201426“Comparison of 6% hydroxyethyl starch 130/0.4 and saline solution for resuscitation of the microcirculation during the early goal-directed therapy of septic patients.” PMID 20813485 ↗ Sep 2010 “6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) 250 mL will be administered over 5 minutes starting immediately after intrathecal injection” NCT03252496 ↗ “Effect of 6% hydroxyethyl starch 130/0.4 on inflammatory response and pulmonary function in patients having cardiac surgery: a randomized clinical trial.” PMID 34406128 ↗ Oct 2021 “6 % Hydroxyethyl Starch 130/0.4 (Voluven®) vs. 5% HSA in Volume Replacement Therapy During Elective Open-heart Surgery in Paediatric Patients” NCT00860405 ↗ “The experiments included 10 mL/kg of 6% hydroxyethyl starch 130/0.4 (Voluven™), 20 mL/kg of Ringer's acetate, and a combination of both” PMID 23718743 ↗ May 2013 “6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) 500 mL will be rapidly infused before spinal anesthesia” NCT02961842 ↗ “500 mL 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride plus 500 mL of ringer's acetate solution” NCT05435573 ↗ “fluid replacement by Voluven(hydroxyethyl starch 130/0.4)” NCT01882075 ↗ |
| Known as | hydroxyethyl starch 130/0.4 (6%) | “Early fluid resuscitation with hydroxyethyl starch 130/0.4 (6%) in severe burn injury: a randomized, controlled, double-blind clinical trial.” PMID 24365167 ↗ Dec 2013 |
| Known as | Hydroxyethyl Starch 130/0.4 and Electrolyte injection | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05728645 ↗ |
| Known as | Volulyte(R) | “The fluid investigated is hydroxyethylstarch (HES) 130/0.4 (Volulyte(R)).” NCT01415284 ↗ |
| Known as | VolulyteTM | “6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM)” NCT01553617 ↗ |
| Known as | voluven | “Patients randomized to the Starch group will receive Voluven (6% Hydroxyethyl Starch 130/0.4) for their intravenous bolus and fluid resuscitation requirements.” NCT00964015 ↗7“6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) 250 mL will be administered over 5 minutes starting immediately after intrathecal injection” NCT03252496 ↗ “individualized goal-directed fluid optimization (cardiac preload) by 250 ml boluses of HES 130/0.4 (up to a maximum of 30 ml/kg, VOLUVEN ®, Fresenius Kabi)” NCT03420261 ↗ “The purpose of this study is to evaluate the safety of a standard volume replacement called HES 130/0.4 (Voluven) during surgery on recovery.” NCT02192502 ↗ “6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) 500 mL will be rapidly infused before spinal anesthesia” NCT02961842 ↗ “patients will receive 6% HES 130/0.4 in NaCl 0.9% (Voluven, Fresenius Kabi, Bad Hom-bourg, Germany)” NCT01670604 ↗ “Non balanced Hydroxyethyl starch 130/0.4 (Voluven®, Fresenius)” NCT02906514 ↗ “fluid replacement by Voluven(hydroxyethyl starch 130/0.4)” NCT01882075 ↗ |
| Known as | Voluven balanced | “HES 130/0.4 (6%), Voluven balanced vs. Lactated Ringer's solution” NCT01012648 ↗ |
| Modality | Other / unclassified | “Voluven (130/0.4) is a medium molecular weight hydroxyethyl starch (HES)” NCT00308100 ↗ |
| Route | Intravenous | “Voluven® was administered intravenously.” NCT00464204 ↗ |