Prospective, Controlled, Single-blind, Bicentric, Randomized Study on the Safety of HES 130/0.42 Combined With a Bal. Electr. Sol. vs 5% Albumin Comb. With an Unbal. Electr. Sol. (NaCl 0.9%) in Pat. With Compensated Renal Failure

B. Braun Melsungen AG2 sites in 1 country2 target enrollmentNovember 2009

Overview

Phase: Phase 4
Intervention: HES 130/0.42 + electrolyte solution
Conditions: Renal Insufficiency
Sponsor: B. Braun Melsungen AG
Enrollment: 2
Locations: 2
Primary Endpoint: Impact of two different volume replacement regimes on base excess in patients with reduced renal function
Status: Terminated
Last Updated: 15 years ago

This investigational study will investigate two different volume replacement regimes in patients suffering from compromised renal function.

Registry

clinicaltrials.gov

Start Date

November 2009

End Date

September 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

HES 130/0.42 + Sterofundin ISO

Intervention: HES 130/0.42 + electrolyte solution

Albumin + NaCl 0.9%

Intervention: Albumin + electrolyte solution

Impact of two different volume replacement regimes on base excess in patients with reduced renal function

Time Frame: from pre-operative assessment until last evaluation of data i.e. 5th (hospital) and 60th postoperative day (follow-up)

Renal function, hemodynamics, blood loss, amount of given blood products, electrolytes, outcome and other data like concomitant medication(inta-/postoperative)