Septic ShockNCT01611753
Red Blood Cell Transfusion Improves Perfusion Parameters in Septic Shock Patients With Hypoperfusion
A study testing packed red blood cell transfusion in people with Septic Shock, run by Bruno Franco Mazza at 1 site in Brazil.
Trial summary
The purpose of this study was to evaluate the immediate effects of red blood cells transfusion on central venous oxygen saturation and lactate levels in septic shock patients randomized to two different hemoglobin levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- packed red blood cell transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2004to Aug 2008
- Phase
- Interventional
- 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 over 18 years old
- less than 48 hours of shock diagnosis
- hemoglobin levels lower than 9.0 g/dL
- a central venous catheter in the superior vena cava
- signed informed consent. The exclusion criteria were
Who cannot join
- pregnancy
- known coronary disease
- active bleeding
- previous participation in the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Sao Paulo - Universitary hospital of Sao Paulo Federal University
São Paulo, São Paulo, 04023-900
About this study
Official title: Red Blood Cell Transfusion Improves Perfusion Parameters in Septic Shock Patients With Hypoperfusion: a Prospective Randomized Study
The purpose of this study was to evaluate the immediate effects of red blood cells transfusion on central venous oxygen saturation and lactate levels in septic shock patients randomized to two different hemoglobin levels.
The influence of red blood cell (RBC) transfusion on the adequacy of oxygen delivery (DO2) and supply (VO2) could be assessed by systemic oxygen variables such as central venous oxygen saturation (ScvO2) and lactate levels. Although it is not clear that alterations in these parameters actually represent an improvement in the DO2/VO2 ratio, they might represent a better transfusion trigger than the absolute hemoglobin value.
Read more
Patients admitted with a diagnosis of septic shock and hemoglobin levels lower than 9.0 g/dL , less than 48 hours of shock diagnosis, were included, a central venous catheter in the superior vena cava and signed informed consent. The investigators randomized all patients into two groups. Patients in the liberal group received transfusions immediately, as the objective was to maintain hemoglobin levels above 9.0 g/dL. In the restrictive group, transfusion was withheld until their hemoglobin levels fell below 7.0 g/dL.
Each time a patient received a transfusion, the investigators collected a set of laboratory tests, including hemoglobin levels, ScvO2 and lactate, at two time points, immediately before transfusion and one hour after its ending.
The sample size was calculated by considering that in 80% of the transfusions in patients in the restrictive group ScvO2 would improve compared to only 45% of those in the liberal group, with an alpha error of 0.05 and 80% power. Improvement was defined as an increase of 5% over the pre-transfusion ScvO2. Twenty-eight transfusions in each group would be necessary, but to correct for potential non-parametric distribution of the main variables, the number was adjusted to 35 transfusions in each group.
Trends in ScvO2 and lactate were categorized as worsening or improving. The investigators defined improvement when ScvO2 reached 70% in patients with baseline levels below this threshold or when there was an absolute increase of at least 5% after transfusion. Any increase in patients with previous ScvO2 ≥ 70% was considered to be "no change". Worsening was defined as a reduction of 5% in the previous levels or a decline to less than 70% in patients with pre-transfusion levels in the range of 70 to 75%. The investigators also carried out a ROC curve analysis to assess the accuracy of the pre-transfusion hemoglobin levels, pre-transfusion lactate and pre-transfusion ScvO2 in predicting the patients whose ScvO2 would increase more than 5% with transfusion. For this analysis, the investigators used a different approach because it would also be necessary to analyze patients with a lower chance of response to assess the prediction of response. Thus, this analysis included all patients with ScvO2 below 75%, rather than only those below 70%. As before, the investigators defined improvement as any increase ≥ 5%. The investigators did not consider patients with levels above 75% in this analysis, as the physiological interpretation of this situation is challenging. The investigators considered as altered any lactate levels above 1.5 times the reference level, and a change ≥ 10% was defined as improvement or worsening. In patients with baseline normal levels, the status was recorded as worsening if a 10% increase was detected. Afterwards, the investigators tested the association between these categorized variables and the baseline levels of hemoglobin. The impact on perfusion was also assessed by the determination of Δlactate (lactate post-transfusion x 100/lactate pre-transfusion) and ΔScvO2 (ScvO2 post-transfusion x 100/ScvO2 pre-transfusion), and their correlation with the baseline hemoglobin levels was analyzed using the Spearman correlation test.
In all tests, the results were considered significant if the p level was lower than 0.05.
- Conditions
- Septic Shock
- Being tested
- packed red blood cell transfusion
- Keywords
- Shock, Septic, Erythrocyte Transfusion, Ischemia
- Medical subject headings
- Shock, Septic, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
packed red blood cell transfusionOther
Patients wil be randomized en two groups, in the liberal group they must received transfusions immediately, as the objective was to maintain hemoglobin levels above 9.0 g/dL. In the restrictive group they will receive transfusion to maintain hemoglobin levels above 7.0g/dL
| Study group | Role | What they receive |
|---|---|---|
| liberal group | Active comparator | Patients in the liberal group received transfusions immediately, as the objective was to maintain hemoglobin levels above 9.0 g/dL. Receives: Other: packed red blood cell transfusion |
| restrictive group | Active comparator | Patients in the liberal group received transfusions immediately, as the objective was to maintain hemoglobin levels above 7.0 g/dL. Receives: Other: packed red blood cell transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the change in baseline levels of lactate and central venous saturation effects after red blood cells transfusion in patients of septic shock
Measured: The purpose of this study was to evaluate the effects of red blood cells transfusion on central venous oxygen saturation and lactate levels after 1 hour in septic shock patients randomized to two different hemoglobin levels
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startApr 2004
- Primary completionAug 2008
- Study completionAug 2008
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.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bruno Franco Mazza
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bruno Franco Mazza, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611753
- Sponsor's protocol ID
- 1177/04
- Status last verified
- May 2012
- First submitted
- 24 May 2012
- Last updated
- 5 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Mazza BF, Freitas FG, Barros MM, Azevedo LC, Machado FR. Blood transfusions in septic shock: is 7.0 g/dL really the appropriate threshold? Rev Bras Ter Intensiva. 2015 Jan-Mar;27(1):36-43. doi: 10.5935/0103-507X.20150007. Epub 2015 Mar 1.
PubMed 25909311
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Red Blood Cell Transfusion Improves Perfusion Parameters in Septic Shock Patients With Hypoperfusion: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01611753
- Acronym / sponsor ID
- 1177/04
- Conditions
- Septic Shock
- Keywords
- Shock, Septic, Erythrocyte Transfusion, Ischemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Bruno Franco MazzaUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 5 Jun 2012 (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 purpose of this study was to evaluate the immediate effects of red blood cells transfusion on central venous oxygen saturation and lactate levels in septic shock patients randomized to two different hemoglobin levels.
The influence of red blood cell (RBC) transfusion on the adequacy of oxygen delivery (DO2) and supply (VO2) could be assessed by systemic oxygen variables such as central venous oxygen saturation (ScvO2) and lactate levels. Although it is not clear that alterations in these parameters actually represent an improvement in the DO2/VO2 ratio, they might represent a better transfusion trigger than the absolute hemoglobin value.
Patients admitted with a diagnosis of septic shock and hemoglobin levels lower than 9.0 g/dL , less than 48 hours of shock diagnosis, were included, a central venous catheter in the superior vena cava and signed informed consent. The investigators randomized all patients into two groups. Patients in the liberal group received transfusions immediately, as the objective was to maintain hemoglobin levels above 9.0 g/dL. In the restrictive group, transfusion was withheld until their hemoglobin levels fell below 7.0 g/dL.
Each time a patient received a transfusion, the investigators collected a set of laboratory tests, including hemoglobin levels, ScvO2 and lactate, at two time points, immediately before transfusion and one hour after its ending.
The sample size was calculated by considering that in 80% of the transfusions in patients in the restrictive group ScvO2 would improve compared to only 45% of those in the liberal group, with an alpha error of 0.05 and 80% power. Improvement was defined as an increase of 5% over the pre-transfusion ScvO2. Twenty-eight transfusions in each group would be necessary, but to correct for potential non-parametric distribution of the main variables, the number was adjusted to 35 transfusions in each group.
Trends in ScvO2 and lactate were categorized as worsening or improving. The investigators defined improvement when ScvO2 reached 70% in patients with baseline levels below this threshold or when there was an absolute increase of at least 5% after transfusion. Any increase in patients with previous ScvO2 ≥ 70% was considered to be "no change". Worsening was defined as a reduction of 5% in the previous levels or a decline to less than 70% in patients with pre-transfusion levels in the range of 70 to 75%. The investigators also carried out a ROC curve analysis to assess the accuracy of the pre-transfusion hemoglobin levels, pre-transfusion lactate and pre-transfusion ScvO2 in predicting the patients whose ScvO2 would increase more than 5% with transfusion. For this analysis, the investigators used a different approach because it would also be necessary to analyze patients with a lower chance of response to assess the prediction of response. Thus, this analysis included all patients with ScvO2 below 75%, rather than only those below 70%. As before, the investigators defined improvement as any increase ≥ 5%. The investigators did not consider patients with levels above 75% in this analysis, as the physiological interpretation of this situation is challenging. The investigators considered as altered any lactate levels above 1.5 times the reference level, and a change ≥ 10% was defined as improvement or worsening. In patients with baseline normal levels, the status was recorded as worsening if a 10% increase was detected. Afterwards, the investigators tested the association between these categorized variables and the baseline levels of hemoglobin. The impact on perfusion was also assessed by the determination of Δlactate (lactate post-transfusion x 100/lactate pre-transfusion) and ΔScvO2 (ScvO2 post-transfusion x 100/ScvO2 pre-transfusion), and their correlation with the baseline hemoglobin levels was analyzed using the Spearman correlation test.
In all tests, the results were considered significant if the p level was lower than 0.05.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| liberal group | Active comparator | Other: packed red blood cell transfusionPatients in the liberal group received transfusions immediately, as the objective was to maintain hemoglobin levels above 9.0 g/dL. |
| restrictive group | Active comparator | Other: packed red blood cell transfusionPatients in the liberal group received transfusions immediately, as the objective was to maintain hemoglobin levels above 7.0 g/dL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age over 18 years old
- less than 48 hours of shock diagnosis
- hemoglobin levels lower than 9.0 g/dL
- a central venous catheter in the superior vena cava
- signed informed consent. The exclusion criteria were
Key exclusion criteria (4 listed)
- pregnancy
- known coronary disease
- active bleeding
- previous participation in the study.
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 |
|---|---|---|
| packed red blood cell transfusionPatients wil be randomized en two groups, in the liberal group they must received transfusions immediately, as the objective was to maintain hemoglobin levels above 9.0 g/dL. In the restrictive group they will receive transfusion to maintain hemoglobin levels above 7.0g/dL | Other | liberal group, restrictive group |
Primary outcome
Evaluate the change in baseline levels of lactate and central venous saturation effects after red blood cells transfusion in patients of septic shock
Time frame: The purpose of this study was to evaluate the effects of red blood cells transfusion on central venous oxygen saturation and lactate levels after 1 hour in septic shock patients randomized to two different hemoglobin levels
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 Jun 2012.
- Derived from this study: PubMed 25909311Mazza BF, Freitas FG, Barros MM, Azevedo LC, Machado FR. Blood transfusions in septic shock: is 7.0 g/dL really the appropriate threshold? Rev Bras Ter Intensiva. 2015 Jan-Mar;27(1):36-43. doi: 10.5935/0103-507X.20150007. Epub 2015 Mar 1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing packed red blood cell transfusion in people with Septic Shock, run by Bruno Franco Mazza 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 5 inclusion and 4 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 Jun 2012. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Evaluate the change in baseline levels of lactate and central venous saturation effects after red blood cells transfusion in patients of septic shock (time frame: The purpose of this study was to evaluate the effects of red blood cells transfusion on central venous oxygen saturation and lactate levels after 1 hour in septic shock patients randomized to two different hemoglobin levels). 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 NCT01611753, 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 Jun 2012.