Clinical trials: Hydroxyethyl Starch
Brain Hypoperfusion
Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection as Adjunctive Therapy in Subjects With Internal Carotid Artery Hypoperfusion
The aim of this study is to evaluate the effectiveness, safety and tolerability of consistent dosages of the study drug (hydroxyethyl starch 130/0.4 and sodium chloride injection, Vuloven) administrated intravenously for 7 days.
- Trial name
- NCT01192581
- Testing
- hydroxyethyl starch 130/0.4 and sodium chloride injection
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Xijing Hospital
Perioperative Volume Replacement, Hydroxyethyl Starch
Safety and Efficacy of Perioperative Volume Replacement with Volulyte 6% in Moderate-to-high Cardiovascular Risk Patients Having Major Abdominal Surgery
The investigators propose a multicenter randomized trial to test the renal safety of 6% hydroxyethyl starch (HES) 130/0.4 combined with sodium acetate Ringer's crystalloid solution in moderate-to-high cardiovascular risk patients…
- Trial name
- NCT06663254
- Testing
- Hydroxyethyl starch 130/0.4, Sodium acetate Ringer
- Where
- 6 sites in China
- Volunteers
- 410 people
- Sponsor
- Xiangya Hospital of Central South University
Hypotension, Ischemia
Phase III Study of Hemospan® to Prevent Hypotension in Hip Arthroplasty
The purpose of this study is to determine whether Hemospan is superior to Voluven for preventing hypotensive episodes during the perioperative period (from induction of spinal anesthesia until 6 hours after skin closure), and for…
- Trial name
- NCT00421200
- Testing
- Hemospan (MP4OX), Voluven (HES 130/0.4)
- Where
- 18 sites in Belgium, Czechia and 4 more
- Volunteers
- 375 people
- Sponsor
- Sangart
Postoperative Morbidity, Postoperative Mortality
Fluid Loading in Abdominal Surgery: Saline Versus Hydroxyethyl Starch (FLASH Study)
The primary purpose of the study is to evaluate whether the type of fluid (0.9% saline or 6% Hydroxyethyl starch 130/0.4) in the context of an individualized goal-directed fluid therapy is associated with a difference in…
- Trial name
- FLASH (NCT02502773)
- Testing
- Hydroxethyl starch
- Where
- France
- Volunteers
- 826 people
- Sponsor
- University Hospital, Clermont-Ferrand
Postoperative Inflammation
A Comparative Study of Volume Replacement With HES 130/0.4 Versus Ringer's Lactate (RL) Regarding Their Effects on Inflammatory Biomarkers (Cytokines and Matrix Metalloproteinases) Responses to Major Abdominal Surgery.
Various stimuli such as trauma, infection and major surgery may alter the physiologic immune balance and initiate systemic inflammatory processes.
- Trial name
- NCT01880190
- Testing
- Ringer's Lactate, HES 130/0.4 and Ringer's Lactate
- Where
- Greece
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Paraskevi Matsota
Osteoarthritis
Hydroxyethyl Starch and Renal Function After Hip Replacement Surgery
The purpose of this project is to investigate if hydroxyethyl starch (HES) is potential nephrotoxic and examine the effects on the circulation and kidneys during administration of HES during surgery.
- Trial name
- VOHO (NCT01486576)
- Testing
- Voluven (Hydroxyethyl starch 130/0,4), Sodium Chloride 9 mg/ml
- Where
- Denmark
- Volunteers
- 42 people
- Sponsor
- Regional Hospital Holstebro
Postoperative Hemorrhage
Hetastarch and Bleeding Complications After Off-Pump Coronary Bypass Surgery
There has been continuing debate about whether use of hetastarch for volume replacement in coronary artery bypass surgery [CABG] increases the risk of postoperative bleeding.
- Trial name
- NCT00307138
- Testing
- hetastarch
- Where
- United States
- Volunteers
- 330 people
- Sponsor
- Kaiser Permanente
Plasma Volume Replacement
Safety Profile of Hydroxyethyl Starch
The study is primarily aimed to collect further data on the safety of the investigational product in a large patient population when used in routine clinical practice in the Asian-Pacific region.
- Trial name
- NCT01304433
- Testing
- Venofundin 6% / Tetraspan 6%
- Where
- 6 sites in China, Malaysia
- Volunteers
- 1,000 people
- Sponsor
- B. Braun Melsungen AG
Heart; Dysfunction Postoperative, Cardiac Surgery
VolulyteTM in Cardiac Surgery
The study will compare the efficacy and safety of VolulyteTM and human albumin in elective open-heart surgery in adult patients.
- Trial name
- NCT01553617
- Testing
- 6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM), Human serum albumin
- Where
- 5 sites in Canada
- Volunteers
- 133 people
- Sponsor
- Fresenius Kabi
Decreased and Nonspecific Blood Pressure Disorders and Shock
Comparison of HES 130 in Balanced and in Unbalanced Solution
The purpose of this study is to evaluate the efficacy of HES 130/0.42 in an electrolyte infusion in comparison to HES 130/0.4 in a sodium chloride infusion.
- Trial name
- NCT01301469
- Testing
- 6% HES 130/0.42 in plasma adapted Ringer's solution, 6% HES 130/0.4 in a saline solution
- Where
- 4 sites in China
- Volunteers
- 240 people
- Sponsor
- B. Braun Melsungen AG
Coronary Heart Disease
Efficacy and Safety of Hypertonic Sodium Lactate Solution Compared With 6% HES Solution in CABG Patients
The choice of fluid therapy is controversial in cardiac surgery. Numerous studies have shown that colloid is better as compared to crystalloids.
- Trial name
- NCT01654653
- Testing
- Hypertonic sodium lactate, 6% Hydroxy Ethyl Starch
- Where
- Indonesia
- Volunteers
- 100 people
- Sponsor
- Innogene Kalbiotech Pte. Ltd
Obstetric Anesthesia, Spinal Anesthesia
ED50 Determination of Hydroxyethylstarch for Treatment of Hypotension During Cesarean Section Under Spinal Anesthesia
The purpose of this trial is to determine the effective volume of hydroxyethylstarch 130/0.4 which would prevent the occurence of maternal hypotension in 50% of healthy pregnant women undergoing a cesarean section under spinal…
- Conditions
- Obstetric Anesthesia, Spinal Anesthesia, Hypotension, Fluid Therapy
- Trial name
- NCT01415284
- Testing
- Hydroxyethylstarch 130/0.4
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- Maisonneuve-Rosemont Hospital
Vascular Disease, Critical Lower Limb Ischemia
Pilot Study of Hemospan® in Patients With Chronic Critical Limb Ischemia
The purpose of this study is to evaluate the effects of Hemospan infusion on vascular reactivity, regional perfusion and oxygenation of ischemic tissue in patients with chronic critical lower limb ischemia.
- Trial name
- NCT00633659
- Testing
- Hemospan (MP4OX), Voluven (HES 130/0.4)
- Where
- Sweden
- Volunteers
- 6 people
- Sponsor
- Sangart
Coagulopathy
Comparison Between Colloids and Crystalloids on Coagulation and Blood Loss
Infusion of intravenous fluids is mandatory especially in major and prolonged surgeries. However, there is no available optimum ideal type of fluid nor a fixed amount suitable for transfusion but it must be individualized for…
- Trial name
- NCT06683079
- Where
- Egypt
- Volunteers
- 40 people
- Sponsor
- Assiut University
Postoperative Morbidity, Postoperative Mortality
Hemostasis Evolution During Fluid Loading in Abdominal Surgery. Effects of Fluid Choice: Saline Versus Hydroxyethyl Starch (HAEMO Study)
The primary purpose of the study is to evaluate whether the type of fluid (0.9% saline or 6% Hydroxyethyl starch 130/0.4) in the context of an individualized goal-directed fluid therapy is associated with a difference in…
- Conditions
- Postoperative Morbidity, Postoperative Mortality, Hemostasis Change
- Trial name
- HAEMO (NCT03420261)
- Testing
- 0.9% saline, HES 130/0.4
- Where
- France
- Volunteers
- 56 people
- Sponsor
- University Hospital, Clermont-Ferrand
Intracranial Hypotension
HES Patch Versus Blood Patch
The injection of autologous blood Blood Patch (BP) into the epidural space is the standard treatment for headache associated with intracranial hypotension. It provokes cerebral vasoconstriction.
- Trial name
- NCT02570724
- Testing
- injection of HES " Voluven® ", blood patch
- Where
- France
- Volunteers
- 20 people
- Sponsor
- University Hospital, Strasbourg, France
Burns
Early Fluid Resuscitation With Balanced HES 130/0.4 [6%] in Severe Burn Injury
RCT colloids versus cristalloids only in severe burn victims. Trial with medicinal product
- Trial name
- NCT01012648
- Testing
- Fluid resuscitation, HES 130/0.4 (6%), Voluven balanced vs. Lactated Ringer's solution
- Where
- Switzerland
- Volunteers
- 48 people
- Sponsor
- University of Zurich
Hypovolemia Due to Acute Blood Loss
Safety and Efficacy of a 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Trauma Patients
The aim of the study is to investigate the safety of a 6% hydroxyethyl starch (HES) solution (Volulyte 6%) versus an electrolyte solution (Ionolyte) in trauma patients.
- Trial name
- TETHYS (NCT03338218)
- Testing
- Volulyte 6%, Ionolyte
- Where
- 22 sites in Belgium, Czechia and 5 more
- Volunteers
- 238 people
- Sponsor
- Fresenius Kabi
Valvular Heart Disease, Coronary Artery Disease
Humanalbumin, Hydroxyethylstarch and Ringer Lactate During Cardiac Surgery
The aim of the study is to compare three different regimens for volume replacement during cardiac surgery, e.g. Albumin 5%, Hydroxyethylstarch 130/0.4 (HES) and Ringer-Lactate (RL).
- Trial name
- NCT01174719
- Testing
- volume replacement, Humanalbumin 5%
- Where
- Austria
- Volunteers
- 240 people
- Sponsor
- Medical University of Vienna
Sepsis
Effects of Voluven on Hemodynamics and Tolerability of Enteral Nutrition in Patients With Severe Sepsis
The rapidity and the quality of fluid resuscitation in patients with severe sepsis are important factors for the prevention of secondary multi-organ failure.
- Trial name
- CRYSTMAS (NCT00464204)
- Testing
- 6 % Hydroxyethylstarch 130/0.4 = "Voluven®", 0.9 % NaCl
- Where
- 24 sites in France, Germany
- Volunteers
- 196 people
- Sponsor
- Fresenius Kabi