Systemic Inflammatory Response SyndromePhase 2BLISSNCT00706771
Bicarbonate and Lipocalin in Systemic Inflammatory Response Syndrome (SIRS) Study
A Phase 2 study testing Sodium bicarbonate and Sodium chloride in people with Systemic Inflammatory Response Syndrome and Oliguria, run by Austin Health at 2 sites in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Inflammatory Response Syndrome, Oliguria, Renal Impairment
- What is being tested?
- Sodium bicarbonate and Sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesAustralia
- Study dates
- Feb 2010to Sep 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consent obtained
- Diagnosis of SIRS. Requires any TWO of:
- temperature > 38°C or < 36°C OR heart rate > 90 beats/min OR respiratory rate > 20 breaths/min. PaCO2 < 32 mm Hg OR alteration of white blood cell count > 12,000 cells/mm3, < 4,000 cells/mm3, or the presence of > 10% immature neutrophils
- elevated lipocalin level
- Arterial line already in place
- Central venous catheter already in place
- Age ≥ 18 years
- Within 24 hours of admission to the ICU
Who cannot join
- Unlikely to remain in ICU for >72 hours
- Moribund patient
- Pre-existing CKD, transplant or ESRD
- Receiving (or about to receive) continuous renal replacement therapy for acute renal failure at time of enrolment
- Diagnosis of acute GN, AIN, vasculitis or post-renal aetiology
- Known/suspected study allergy to sodium bicarbonate
- Enrolling physician concern about patient enrolment
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Austin Hospital
Heidelberg, Melbourne, Victoria, 3084
Royal Melbourne Hospital
Melbourne, Victoria, 3154
About this study
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, Oliguria and Elevated Lipocalin Levels
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).
Read the detailed description
The investigators hypothesise:
- 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.
- 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.
- 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.
- Being tested
- Sodium bicarbonate, Sodium chloride
- Keywords
- sodium bicarbonate, serum neutrophil gelatinase associated lipocalin, renal impairment, renal failure, systemic inflammatory response syndrome, defined, by serum NGAL ≥ 100 ng/ml.
- Medical subject headings
- Systemic Inflammatory Response Syndrome, Oliguria, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium bicarbonateDrug
Sodium bicarbonate: loading dose of 0.5 mmol/Kg and then continuous infusion of 0.2 mmol/Kg/hr
Sodium chlorideDrug
0.9% sodium chloride: loading dose of 0.5 mmol/Kg and then continuous infusion of 0.2 mmol/Kg/hr
| Study group | Role | What they receive |
|---|---|---|
| Sodium bicarbonate | Active comparator | sodium bicarbonate: loading of 0.5 mmol/kg and the continuous infusion o f0.2 mmol/kg/hr Receives: Drug: Sodium bicarbonate |
| Sodium chloride | Active comparator | sodium chloride: loading of 0.5 mmol/kg and the continuous infusion o f0.2 mmol/kg/hr Receives: Drug: Sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ability to deliver the study protocol safely and rapidly with a trend to improved renal outcomes
Measured: 28 days
Secondary outcomes (3)
Attenuation in lipocalin levels
Measured: 28 days
Decrease in the magnitude in serum creatinine rise
Measured: 28 days
Ability to deliver the study protocol without significant biochemical side effects
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2008 (estimated)
- Study startFeb 2010
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Inflammatory Response SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Austin Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Rinaldo Bellomo, Austin Health
- Investigators
- Michael C Reade, MBBS DPhil, Principal investigator, Austin & Northern Hospitals, University of MelbourneNerina Harley, MBBS FCICM, Principal investigator, Melbourne HealthRinaldo Bellomo, MD FJFICM, Principal investigator, Austin Hospital, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706771
- Sponsor's protocol ID
- TNH 18/08
- Acronym
- BLISS
- Status last verified
- Jun 2014
- First submitted
- 26 Jun 2008
- Last updated
- 30 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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, Oliguria and Elevated Lipocalin Levels
- ClinicalTrials.gov ID
- NCT00706771
- Acronym / sponsor ID
- BLISS / TNH 18/08
- Keywords
- sodium bicarbonate, serum neutrophil gelatinase associated lipocalin, renal impairment, renal failure, systemic inflammatory response syndrome, defined, by serum NGAL ≥ 100 ng/ml.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Austin HealthOther government
- Study start
- Feb 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 30 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
The investigators hypothesise:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium bicarbonate | Active comparator | Drug: Sodium bicarbonatesodium bicarbonate: loading of 0.5 mmol/kg and the continuous infusion o f0.2 mmol/kg/hr |
| Sodium chloride | Active comparator | Drug: Sodium chloridesodium chloride: loading of 0.5 mmol/kg and the continuous infusion o f0.2 mmol/kg/hr |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Consent obtained
- Diagnosis of SIRS. Requires any TWO of:
- temperature > 38°C or < 36°C OR heart rate > 90 beats/min OR respiratory rate > 20 breaths/min. PaCO2 < 32 mm Hg OR alteration of white blood cell count > 12,000 cells/mm3, < 4,000 cells/mm3, or the presence of > 10% immature neutrophils
- elevated lipocalin level
- Arterial line already in place
Key exclusion criteria (7 listed)
- Unlikely to remain in ICU for >72 hours
- Moribund patient
- Pre-existing CKD, transplant or ESRD
- Receiving (or about to receive) continuous renal replacement therapy for acute renal failure at time of enrolment
- Diagnosis of acute GN, AIN, vasculitis or post-renal aetiology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium bicarbonateSodium bicarbonate: loading dose of 0.5 mmol/Kg and then continuous infusion of 0.2 mmol/Kg/hr | Drug | Sodium bicarbonate |
| Sodium chloride0.9% sodium chloride: loading dose of 0.5 mmol/Kg and then continuous infusion of 0.2 mmol/Kg/hr | Drug | Sodium chloride |
Primary outcome
The ability to deliver the study protocol safely and rapidly with a trend to improved renal outcomes
Time frame: 28 days
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael C Reade, MBBS DPhil principal investigator
Austin & Northern Hospitals, University of Melbourne
Nerina Harley, MBBS FCICM principal investigator
Melbourne Health
Rinaldo Bellomo, MD FJFICM principal investigator
Austin Hospital, University of Melbourne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium bicarbonate and Sodium chloride in people with Systemic Inflammatory Response Syndrome and Oliguria, run by Austin Health at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ability to deliver the study protocol safely and rapidly with a trend to improved renal outcomes (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2014.