NCT01418521

Brief Summary

The purpose of this randomized controlled trial in patients undergoing cardiac surgery is to show that a 3rd generation HES (Hydroxyethyl Starch) solution - Tetraspan® is as good as in terms of safety and effectiveness as the commonly used albumin based solution for volume replacement after the surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 17, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

August 17, 2011

Status Verified

August 1, 2011

Enrollment Period

1.9 years

First QC Date

August 9, 2011

Last Update Submit

August 16, 2011

Conditions

Elective Cardiac Surgery

Keywords

Cardiac surgeryBalanced 3rd generation Hydroxyethyl starchTetraspanRinger-albumin

Outcome Measures

Primary Outcomes (1)

  • Chest tube drainage volume

    Total volume at the time of removal of drains (48 hours after surgery on average)

Secondary Outcomes (6)

  • Volume of replacement fluids given after surgery at each group

    Summary of volume replacement at the time of discharge from ICU (48 hours after surgery on average)

  • In hospital - all cause mortality

    End of hospitalization (5 days postsurgery on average)

  • 30-days all cause mortality

    30 days from surgery

  • Incidence of kidney injury as defined by RIFLE criteria

    Duration of hospitalization after surgery (expected average duration of 5 days)

  • Incidence of coagulopathy as defined by prolonged PT\PTT and abnormal thromboelastogram not due to clotting inhibitors during hospitalization.

    Duration of hospitalization after surgery (expected average duration of 5 days)

  • +1 more secondary outcomes

Study Arms (2)

Ringer-albumin

ACTIVE COMPARATOR

Patients receiving the standard care of ringer-albumin as volume replacement after cardiac surgery

Drug: Ringer- albumin

Tetraspan

EXPERIMENTAL

patients receiving a 3rd generation HES solution (tetraspan) for volume replacement after cardiac surgery

Drug: Balanced hydroxyethyl starch solution

Interventions

Balanced hydroxyethyl starch solutionDRUG

Patients receiving Tetraspan 6% ( a balanced 3rd generation Hydroxyethyl starch)for volume replacement after elective cardiac surgery as needed.

Also known as: Tetraspan
Tetraspan
Ringer- albuminDRUG

Patients receiving lactated ringer-albumin solution for volume replacement after cardiac surgery

Also known as: HARTMANN Solution, Human albumin 20%- Zenalb
Ringer-albumin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent must be obtained from the subject or his/her legal guardian before any assessment is performed.
  • Male or Female subject, 18 years or older.
  • Any elective cardiac surgery

You may not qualify if:

  • Subjects with impaired liver function defined as an elevated level of ALT and AST over 100 U/L.
  • Hyperhydration states (e.g. pulmonary edema, congestive heart failure).
  • Renal failure with creatinine blood levels \> 2.5 mg/dL or eGFR \< 30 ml/min (calculated using the DMRD formula).
  • Oliguria (UO\<0.5ml\\kg\\hr) or anuria (not related to hypovolemia) more than 12 hours.
  • Current Intracranial hemorrhage.
  • Current, hard to balance hyperkalemia.
  • Severe hypernatremia or severe hyperchloremia.
  • Known hypersensitivity to hydroxyethyl starch or to any of the excipients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam health care campus

Haifa, Israel

Location

MeSH Terms

Interventions

Serum Albumin, Human

Intervention Hierarchy (Ancestors)

Serum AlbuminAlbuminsProteinsAmino Acids, Peptides, and ProteinsBlood Proteins

Study Officials

  • Zvi Adler, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liran Shani, MD

CONTACT

972-8542631l_shani@rambam.health.gov.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 9, 2011

First Posted

August 17, 2011

Study Start

August 1, 2011

Primary Completion

July 1, 2013

Study Completion

August 1, 2013

Last Updated

August 17, 2011

Record last verified: 2011-08

Locations

IL(1)