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Safety and Efficacy of a 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Trauma Patients (TETHYS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03338218
Recruitment Status : Active, not recruiting
First Posted : November 9, 2017
Last Update Posted : May 27, 2022
Sponsor:
Collaborators:
B. Braun Melsungen AG
European Society of Anaesthesiology and Intensive Care
Information provided by (Responsible Party):
Fresenius Kabi

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypovolemia Due to Acute Blood Loss Drug: Volulyte 6% Drug: Ionolyte Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pragmatic, Prospective, Randomized, Controlled, Double-blind, Multi-centre, Multinational Study on the Safety and Efficacy of a 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Trauma Patients
Actual Study Start Date : February 23, 2019
Estimated Primary Completion Date : July 9, 2022
Estimated Study Completion Date : July 9, 2022


Arm Intervention/treatment
Experimental: Volulyte 6%
Volulyte 6% solution for infusion
Drug: Volulyte 6%
Solution for infusion
Other Name: Hydroxyethyl starch 130

Active Comparator: Ionolyte
Ionolyte solution for infusion
Drug: Ionolyte
Solution for infusion
Other Name: Ionolyte Electrolyte Solution




Primary Outcome Measures :
  1. Composite endpoint of 90 day mortality and 90 day renal failure defined as biomarker increase as defined by AKIN stage 2 or RIFLE injury stage or need for RRT at any time during the first 3 months. [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Serum creatinine [ Time Frame: 7 days post-trauma ]
  2. Serum creatinine-based estimated glomerular filtration rate [ Time Frame: 7 days post-trauma ]
  3. Cystatin-C [ Time Frame: 3 days post-trauma ]
  4. Cystatin-C-based mean estimated glomerular filtration rate [ Time Frame: 3 days post-trauma ]
  5. AKIN stages [ Time Frame: 7 days post-trauma ]
  6. Highest AKIN stage reached on each day during the first week [ Time Frame: 7 days post-trauma ]
  7. RIFLE stages [ Time Frame: 7 days post-trauma ]
  8. Urine output (if available) [ Time Frame: 7 days post-trauma ]
  9. Days on Renal Replacement Therapy [ Time Frame: 90 days after randomization ]
  10. Patients on Renal Replacement Therapy [ Time Frame: 90 days after randomization ]
  11. Platelet count [ Time Frame: 3 days post-trauma ]
  12. International normalized ratio [ Time Frame: 3 days post-trauma ]
  13. Activated partial thromboplastin time [ Time Frame: 3 days post-trauma ]
  14. Adverse Events [ Time Frame: 90 days after randomization ]
  15. Mortality [ Time Frame: 90 days after randomization ]
  16. Length of Stay in ICU/hospital [ Time Frame: 90 days after randomization ]
  17. C-reactive protein [ Time Frame: 3 days post-trauma ]
  18. Hours on mechanical ventilation [ Time Frame: 7 days post-trauma ]
  19. Total volume of administered investigational products [ Time Frame: until 24 hours after investigational product treatment start ]
  20. Fluid balance [ Time Frame: 7 days post-trauma ]
    Sum of volume of all intravenous medication (including investigational product and blood products) minus sum of volume of urine output (if available), drainage and estimated due to surgeries and trauma

  21. Heart rate [ Time Frame: 7 days post-trauma ]
  22. Temperature [ Time Frame: 7 days post-trauma ]
  23. Mean arterial pressure [ Time Frame: 7 days post-trauma ]
  24. Systolic arterial blood pressure [ Time Frame: 7 days post-trauma ]
  25. Diastolic arterial blood pressure [ Time Frame: 7 days post-trauma ]
  26. Central venous pressure (if available) [ Time Frame: 7 days post-trauma ]
  27. Partial pressure of carbon dioxide [ Time Frame: 3 days post-trauma ]
  28. Partial pressure of oxygen [ Time Frame: 3 days post-trauma ]
  29. Bicarbonate [ Time Frame: 3 days post-trauma ]
  30. Arterial oxygen saturation [ Time Frame: 3 days post-trauma ]
  31. Hemoglobin [ Time Frame: 3 days post-trauma ]
  32. Hematocrit [ Time Frame: 3 days post-trauma ]
  33. pH [ Time Frame: 3 days post-trauma ]
  34. Base excess [ Time Frame: 3 days post-trauma ]
  35. Lactate [ Time Frame: 3 days post-trauma ]
  36. Central venous oxygen saturation (if available) [ Time Frame: 3 days post-trauma ]
  37. Serum sodium [ Time Frame: 3 days post-trauma ]
  38. Serum potassium [ Time Frame: 3 days post-trauma ]
  39. Serum calcium [ Time Frame: 3 days post-trauma ]
  40. Serum chloride [ Time Frame: 3 days post-trauma ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • Male or female adult patients ≥18 years of age. Women of child bearing potential must test negative on standard pregnancy test (urine or serum) (as soon as possible during emergency care)
  • Patients with blunt or penetrating trauma suffering from estimated blood loss of ≥ 500 ml
  • Initial surgery deemed necessary within 24 hrs after trauma
  • Deferred signed written informed consent form or as locally required
  • No signs of intracranial or cerebral hemorrhage
  • Administration of less than 15 ml/kg body weight colloid between trauma injury and hospital admission.

Exclusion:

  • Hypersensitivity to the active substances or to any of the other excipients of the Investigational Products
  • Body weight ≥ 140 kg
  • Patients expected to die within 24h after traumatic injury
  • Sepsis
  • Burns
  • Renal impairment (AKIN stage ≥ 1 or chronic) or acute and/or chronic Renal Replacement Therapy
  • Critically ill patients (typically admitted to the intensive care unit)
  • Hyperhydration
  • Pulmonary edema
  • Dehydration
  • Hyperkalemia
  • Severe hypernatremia
  • Severe hyperchloremia
  • Severely impaired hepatic function
  • Congestive heart failure
  • Severe coagulopathy
  • Organ transplant patients
  • Metabolic alkalosis
  • Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338218


Locations
Show Show 22 study locations
Sponsors and Collaborators
Fresenius Kabi
B. Braun Melsungen AG
European Society of Anaesthesiology and Intensive Care
Investigators
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Study Chair: Wolfgang F. Buhre, Prof. Dr. med. Department of Anesthesiology and Pain Management, Maastricht University, The Netherlands
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fresenius Kabi
ClinicalTrials.gov Identifier: NCT03338218    
Other Study ID Numbers: HC-G-H-1505
HE06-021-CP4 ( Other Identifier: Fresenius Kabi )
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: May 27, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fresenius Kabi:
Hydroxyethyl starch
HES
HES 130
Additional relevant MeSH terms:
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Hypovolemia
Pathologic Processes