VolulyteTM in Cardiac Surgery
This study is currently recruiting participants.
Verified May 2013 by Fresenius Kabi
Sponsor:
Fresenius Kabi
Information provided by (Responsible Party):
Fresenius Kabi
ClinicalTrials.gov Identifier:
NCT01553617
First received: March 7, 2012
Last updated: May 16, 2013
Last verified: May 2013
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Purpose
The study will compare the efficacy and safety of VolulyteTM and human albumin in elective open-heart surgery in adult patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart; Dysfunction Postoperative, Cardiac Surgery |
Drug: 6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM) Drug: Human serum albumin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Efficacy and Safety of Perioperative Infusion of 6 % Hydroxyethyl Starch 130/0.4 in an Isotonic Electrolyte Solution (VolulyteTM) vs. 5% HSA as Volume Replacement Therapy During Cardiac Surgery for Adult Patients |
Resource links provided by NLM:
Further study details as provided by Fresenius Kabi:
Primary Outcome Measures:
- Calculated red blood cell loss [ Time Frame: up to 3rd postoperative day ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Haemodynamics [ Time Frame: up to 3rd postoperative day ] [ Designated as safety issue: No ]
- Fluid input/output [ Time Frame: up to 3rd postoperative day ] [ Designated as safety issue: No ]Quantity of total fluids administered and excreted or lost from beginning of anaesthesia until 3rd postoperative day
- Use of vasoactive and inotropic drugs [ Time Frame: up to 3rd postoperative day ] [ Designated as safety issue: No ]Type and amount of vasoactive and inotropic drugs administered from beginning of anaesthesia until 3rd postoperative day
- Laboratory parameters [ Time Frame: up to day 28 after surgery ] [ Designated as safety issue: Yes ]Serum creatinine concentration at day 28 after surgery
- Laboratory parameters [ Time Frame: up to 3rd postoperative day ] [ Designated as safety issue: Yes ]set of standard laboratoy parameters before surgery and postoperatively until 3rd postop day
| Estimated Enrollment: | 120 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Volulyte
6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM)
|
Drug: 6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM)
Study drug will be given as part of priming of the ECC and for volume therapy up to the maximum dosage of 50 mL/kg body weight/day
|
|
Active Comparator: Human serum albumin
Human serum albumin (HSA 50g/L)
|
Drug: Human serum albumin
Control drug will be given as part of priming of the ECC and for volume therapy up to the maximum dosage of 50 mL/kg body weight/day
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- male or female adult patients
- undergoing primary elective cardiac surgery applying extracorporeal circulation
- signed written informed consent
Exclusion Criteria:
- known contraindication against scheduled medication
- pre-operative acute normovolaemic haemodilution or preoperative autologous blood donation
- planned systemic hypothermia (body temperature < 30°C)
- expected time on ECC ≥ 2 hours
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01553617
Contacts
| Contact: Joachim Schuetze, PhD | joachim.schuetze@Fresenius-Kabi.com |
Locations
| Canada, British Columbia | |
| Vancouver General Hospital | Not yet recruiting |
| Vancouver, British Columbia, Canada | |
| Contact: Rael Klein, Md PhD 001-604-875-4575 Rael.Klein@vch.ca | |
| Principal Investigator: Rael Klein, MD PhD | |
| Canada, Nova Scotia | |
| Queen Elizabeth II Health Sciences Centre | Not yet recruiting |
| Halifax, Nova Scotia, Canada | |
| Contact: Blaine Kent, MD PhD 001-902-473-2700 blainekent@hotmail.com | |
| Principal Investigator: Blaine Kent, MD PhD | |
| Canada, Ontario | |
| London Health Sciences Centre | Not yet recruiting |
| London, Ontario, Canada | |
| Contact: Phil Jones, MD PhD 001-519-663-3031 Philip.Jones@lhsc.on.ca | |
| Principal Investigator: Phil Jones, MD PhD | |
| Toronto General Hospital | Not yet recruiting |
| Toronto, Ontario, Canada | |
| Contact: George N Djaiani, MD PhD 001-416-340-4800 ext 6205 George.Djaiani@uhn.ca | |
| Principal Investigator: George N Djaiani, MD PhD | |
| St. Michael's Hospital | Recruiting |
| Toronto, Ontario, Canada | |
| Contact: David C Mazer, MD, Professor 001-416-864 ext 5825 mazerd@smh.toronto.on.ca | |
| Principal Investigator: David C Mazer, MD Professor | |
Sponsors and Collaborators
Fresenius Kabi
Investigators
| Principal Investigator: | David C Mazer | St. Michael's Hospital, Department of Anaesthesia, 30 Bond Street, Toronto, Ontario, M5B 1W8, Canada |
More Information
No publications provided
| Responsible Party: | Fresenius Kabi |
| ClinicalTrials.gov Identifier: | NCT01553617 History of Changes |
| Other Study ID Numbers: | VOLU-010-C P4 |
| Study First Received: | March 7, 2012 |
| Last Updated: | May 16, 2013 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
Hetastarch Citric Acid Plasma Substitutes Blood Substitutes Hematologic Agents |
Therapeutic Uses Pharmacologic Actions Anticoagulants Chelating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013