Clinical Trial: Bicarbonate and Lipocalin in Systemic Inflammatory Response Syndrome (SIRS) Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized Double-blind Controlled Pilot Feasibility and Safety Trial of NGAL-directed Sodium Bicarbonate to Protect Renal Function in Patients With the Systemic Inflammatory Response Syndrome,

Brief Summary: The investigators will determine the feasibility, safety and efficacy of intravenous sodium bicarbonate in reducing progression to overt acute renal failure in patients with the systemic inflammatory response syndrome, and low urine output or early acute renal impairment as defined by serum neutrophil gelatinase-associated lipocalin (NGAL).

Detailed Summary:

The investigators hypothesise:

  1. In patients with SIRS and oliguria the early administration of sodium bicarbonate or sodium chloride (control) triggered by an abnormally high NGAL level is feasible.
  2. In patients with SIRS and oliguria the early administration of sodium bicarbonate or sodium chloride (control) triggered by an abnormally high NGAL level is safe.
  3. In patients with SIRS and oliguria the early administration of sodium bicarbonate or sodium chloride (control) triggered by an abnormally high NGAL level leads to signs or trends of efficacy as measured by serum creatinine derived indices.

Sponsor: Austin Health

Current Primary Outcome: The ability to deliver the study protocol safely and rapidly with a trend to improved renal outcomes [ Time Frame: 28 days ]

Original Primary Outcome: The development of renal impairment of at least RIFLE class 'I'. (Crit Care 2004 8(4): R204-12)

Current Secondary Outcome:

  • Attenuation in lipocalin levels [ Time Frame: 28 days ]
  • Decrease in the magnitude in serum creatinine rise [ Time Frame: 28 days ]
  • Ability to deliver the study protocol without significant biochemical side effects [ Time Frame: 28 days ]


Original Secondary Outcome:

  • Institution of renal replacement therapy
  • Duration of ICU stay
  • Duration of hospital stay
  • Hospital mortality
  • Hospital discharge with the ongoing requirement for renal replacement therapy
  • Peak serum NGAL and cystatin C.
  • Peak urine NGAL, IL-18 and cystatin C


Information By: Austin Health

Dates:
Date Received: June 26, 2008
Date Started: February 2010
Date Completion:
Last Updated: June 26, 2014
Last Verified: June 2014