Septic ShockPhase 3RASPNCT01337934
Lactated Ringer Versus Albumin in Early Sepsis Therapy
A Phase 3 study testing Lactated Ringer and Albumin in people with Septic Shock and Severe Sepsis, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The use of albumin in critical ill patients is a matter of controversy. A large randomized controlled trial reported that albumin was as safe and effective as crystalloid solution for fluid replacement in intensive care unit, although the last one was less expensive. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Severe Sepsis
- What is being tested?
- Lactated Ringer and Albumin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2013to Dec 2017
- Phase
- Phase 3
- 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
- Age equal or higher than 18 years-old
- Severe sepsis or septic shock into 6 hours of evolution
- Written informed consent
Who cannot join
- Shock from other causes
- Adverse reactions to human albumin
- Previous fluid resuscitation during current disease
- Previous use of albumin in the last 72 hours
- Religion objection
- Enrollment in another study
Show all 11Show fewer
- Traumatic brain injury
- Hepatic cirrhosis
- End stage renal disease
- Plasmapheresis
- End of life patients
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Cancer Institute of Sao Paulo, School of Medicine, University of Sao Paulo
São Paulo, Sao Paulo/SP, 01246000
About this study
Official title: Ringer Versus Albumin In Septic Patients: a Randomized Controlled Clinical Trial
The use of albumin in critical ill patients is a matter of controversy. A large randomized controlled trial reported that albumin was as safe and effective as crystalloid solution for fluid replacement in intensive care unit, although the last one was less expensive. In Surviving Sepsis Campaign International Guidelines there are no preference for crystalloids over colloids. But recently, a retrospective analysis of patients with severe sepsis from SAFE study reported that the use of albumin in these patients would be superior, regarding reduction of mortality. The aim of this study is determine whether the use of albumin improve clinical outcomes in patients with severe sepsis or septic shock.
- Conditions
- Septic Shock, Severe Sepsis
- Being tested
- Lactated Ringer, Albumin
- Keywords
- Septic shock, Sepsis, Albumin, Lactated Ringer
- Medical subject headings
- Shock, Septic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactated RingerDrug
Lactated Ringer
AlbuminDrug
Albumin 4%
| Study group | Role | What they receive |
|---|---|---|
| Lactated Ringer | Placebo comparator | Patients randomized for this group will receive 500 ml of lactated Ringer solution in early phase of sepsis or septic shock (less than six hour from sepsis onset) if mean arterial pressure was under 65mmHg, or blood lactate concentration higher than 4 mmol/L or base excess under - 4mmol/L until the target of central venous pressure of 8 mmHg or higher or recovery of hypotension. Receives: Drug: Lactated Ringer |
| Albumin | Active comparator | Patients randomized for Albumin group will receive 500 ml of 4% Albumin solution in early phase of sepsis (less than six hour from sepsis onset) if mean arterial pressure was under 65mmHg or blood lactate concentration higher than 4 mmol/L or base excess under - 4mmol/L until the target of central venous pressure of 8 mmHg or higher or recovery of hypotension. Receives: Drug: Albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality in 7 days for any cause
Measured: day 7
Secondary outcomes (7)
Evaluation of sequential organ failure assessment (SOFA) score
Measured: from day 1 until day 7 of care in ICU
ICU length of stay
Measured: day 28
hospital length of stay
Measured: day 28
ventilator-free days
Measured: day 28
Needing of renal replacement therapy
Measured: day 28
days free of vasopressor
Measured: day 28
Mortality in 28-days
Measured: 28 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startOct 2013
- Primary completionOct 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juliano P Almeida, MD, PhD, University of Sao Paulo
- Investigators
- Juliano A Almeida, MD, Study chair, University of Sao PauloLudhmila Hajjar, PhD, Study director, University of Sao PauloClarice H Park, MD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337934
- Sponsor's protocol ID
- 360/10
- Acronym
- RASP
- Status last verified
- Apr 2018
- First submitted
- 13 Apr 2011
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hajjar LA, Vincent JL, Galas FR, Nakamura RE, Silva CM, Santos MH, Fukushima J, Kalil Filho R, Sierra DB, Lopes NH, Mauad T, Roquim AC, Sundin MR, Leao WC, Almeida JP, Pomerantzeff PM, Dallan LO, Jatene FB, Stolf NA, Auler JO Jr. Transfusion requirements after cardiac surgery: the TRACS randomized controlled trial. JAMA. 2010 Oct 13;304(14):1559-67. doi: 10.1001/jama.2010.1446.
PubMed 20940381
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ringer Versus Albumin In Septic Patients: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01337934
- Acronym / sponsor ID
- RASP / 360/10
- Conditions
- Septic Shock, Severe Sepsis
- Keywords
- Septic shock, Sepsis, Albumin, Lactated Ringer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 19 Apr 2011 (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 use of albumin in critical ill patients is a matter of controversy. A large randomized controlled trial reported that albumin was as safe and effective as crystalloid solution for fluid replacement in intensive care unit, although the last one was less expensive. In Surviving Sepsis Campaign International Guidelines there are no preference for crystalloids over colloids. But recently, a retrospective analysis of patients with severe sepsis from SAFE study reported that the use of albumin in these patients would be superior, regarding reduction of mortality. The aim of this study is determine whether the use of albumin improve clinical outcomes in patients with severe sepsis or septic shock.
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 |
|---|---|---|
| Lactated Ringer | Placebo comparator | Drug: Lactated RingerPatients randomized for this group will receive 500 ml of lactated Ringer solution in early phase of sepsis or septic shock (less than six hour from sepsis onset) if mean arterial pressure was under 65mmHg, or blood lactate concentration higher than 4 mmol/L or base excess under - 4mmol/L until the target of central venous pressure of 8 mmHg or higher or recovery of hypotension. |
| Albumin | Active comparator | Drug: AlbuminPatients randomized for Albumin group will receive 500 ml of 4% Albumin solution in early phase of sepsis (less than six hour from sepsis onset) if mean arterial pressure was under 65mmHg or blood lactate concentration higher than 4 mmol/L or base excess under - 4mmol/L until the target of central venous pressure of 8 mmHg or higher or recovery of hypotension. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age equal or higher than 18 years-old
- Severe sepsis or septic shock into 6 hours of evolution
- Written informed consent
Key exclusion criteria (11 listed)
- Shock from other causes
- Adverse reactions to human albumin
- Previous fluid resuscitation during current disease
- Previous use of albumin in the last 72 hours
- Religion objection
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 |
|---|---|---|
| Lactated RingerLactated Ringer | Drug | Lactated Ringer |
| AlbuminAlbumin 4% | Drug | Albumin |
Primary outcome
Mortality in 7 days for any cause
Time frame: day 7
7 secondary outcomes
Evaluation of sequential organ failure assessment (SOFA) score
Time frame: from day 1 until day 7 of care in ICU
ICU length of stay
Time frame: day 28
hospital length of stay
Time frame: day 28
ventilator-free days
Time frame: day 28
Needing of renal replacement therapy
Time frame: day 28
days free of vasopressor
Time frame: day 28
Mortality in 28-days
Time frame: 28 days after randomization
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 5 Apr 2018.
- Background: PubMed 20940381Hajjar LA, Vincent JL, Galas FR, Nakamura RE, Silva CM, Santos MH, Fukushima J, Kalil Filho R, Sierra DB, Lopes NH, Mauad T, Roquim AC, Sundin MR, Leao WC, Almeida JP, Pomerantzeff PM, Dallan LO, Jatene FB, Stolf NA, Auler JO Jr. Transfusion requirements after cardiac surgery: the TRACS randomized controlled trial. JAMA. 2010 Oct 13;304(14):1559-67. doi: 10.1001/jama.2010.1446.
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Sepsis
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.
Juliano A Almeida, MD study chair
University of Sao Paulo
Ludhmila Hajjar, PhD study director
University of Sao Paulo
Clarice H Park, MD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lactated Ringer and Albumin in people with Septic Shock and Severe Sepsis, run by University of Sao Paulo at 1 site in Brazil.
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 3 inclusion and 11 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 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Mortality in 7 days for any cause (time frame: day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01337934, which also lists 1 linked publication.
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 5 Apr 2018.