Septic ShockNCT02453425
The Effects of Blood Pressure on Renal Function and Oxygenation in Septic Shock
A study testing MAP 60 mmHg, MAP 75 mmHg and MAP 90 mmHg in people with Septic Shock and Acute Kidney Injury, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
The purpose of this study is to evaluate renal effects of 3 different levels of mean arterial pressure in early case of septic shock. In 8 patients diagnosed with early septic shock, we will adjust mean arterial pressure (MAP) to three different levels, using norepinephrine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Acute Kidney Injury
- What is being tested?
- MAP 60 mmHg, MAP 75 mmHg and MAP 90 mmHg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSweden
- Study dates
- May 2011to Mar 2017
- 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
- stable septic shock
- normovolemic
- norepinephrine
- intubated/ventilated
- normal s-creatinine according to local laboratory regards.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Sahlgrenska University Hospital, dpt of anesthesiology and intensive care
Gothenburg, VGR, 41345
About this study
Official title: Goal Directed Therapy in Septic Shock - the Effects of Mean Arterial Pressure Levels, Adjusted With Norepinephrine, on Renal Perfusion, Function and Oxygenation.
The purpose of this study is to evaluate renal effects of 3 different levels of mean arterial pressure in early case of septic shock. In 8 patients diagnosed with early septic shock, we will adjust mean arterial pressure (MAP) to three different levels, using norepinephrine. At each level of MAP, central and renal hemodynamics and oxygenation states will be measured. Analysis will be made to describe the pathophysiology at MAP 75 mmHg, and then to evaluate at which MAP renal function and oxygenation is least affected negatively.
Read the detailed description
It is under debate what level of mean arterial pressure is the most appropriate for organ perfusion in septic shock. The kidneys are usually used for end-organ evaluation of appropriate perfusion and appropriate blood pressure level. What "adequate blood pressure" means is today unclear.
The purpose of this study is to chart the renal perfusion, oxygenation and function, and moreover to evaluate renal effects of 3 different levels of mean arterial pressure, in early phase of septic shock.
Patients will be included within the first 24 hrs after admission to the ICU diagnosed with septic shock. The patients will be sedated, mechanically ventilated and in need for norepinephrine for adequate blood pressure levels.
After 60 mins of steady state at MAP 75 mmHg, norepinephrine will be adjusted achieve MAP of 60 and 90 mmHg respectively, MAP being held at each level for 30 mins. At the end of each 30 mins period, central and renal hemodynamics will be measured, blood and urine samples will be collected.
Central hemodynamics will be measured by, and blood samples collected via a pulmonary catheter and an arterial line.
Renal hemodynamics will be measured using a renal vein catheter for retrograde thermodilution giving at hand renal blood flow (RBF), renal vein blood samples and urine collection provides extraction of Cr-EDTA for filtration fraction (FF) and glomerular filtration rate (GFR), renal oxygen consumption, and renal oxygen extraction as a measure of balance between renal oxygen delivery and consumption.
Via renal vein catheterisation and retrograde thermodilution, the study group have the unique possibility to actually evaluate renal blood flow, renal oxygenation and renal function in humans in vivo.
After finishing the data collection, analysis will be made to answer the question: which MAP is the most optimal concerning RBF, GFR and renal oxygenation in patients with septic shock?
- Conditions
- Septic Shock, Acute Kidney Injury
- Being tested
- MAP 60 mmHg, MAP 75 mmHg, MAP 90 mmHg
- Keywords
- renal blood flow, renal oxygenation, glomerular filtration rate, filtration fraction, blood pressure
- Medical subject headings
- Shock, Septic, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAP 60 mmHgOther
Also called Norepinephrine
Norepinephrine adjusted to reach MAP 60 mmHg
MAP 75 mmHgOther
Also called Norepinephrine
Norepinephrine adjusted to reach MAP 75 mmHg
MAP 90 mmHgOther
Also called Norepinephrine
Norepinephrine adjusted to reach MAP 90 mmHg
| Study group | Role | What they receive |
|---|---|---|
| 60 mmHg | Active comparator | Norepinephrine adjusted to reach MAP 60 mmHg Receives: Other: MAP 60 mmHg |
| 75 mmHg | Active comparator | Norepinephrine adjusted to reach MAP 75 mmHg Receives: Other: MAP 75 mmHg |
| 90 mmHg | Active comparator | Norepinephrine adjusted to reach MAP 90 mmHg Receives: Other: MAP 90 mmHg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glomerular filtration rate (GFR)
Renal function, ml/min
Measured: 195 min
Secondary outcomes (4)
Renal Blood Flow (RBF)
ml/min
Measured: 195 mins
Renal Oxygen consumption
ml/min
Measured: 195 mins
Filtration fraction
glomerular filtration rate (GFR) to the renal plasma flow (RPF). Filtration Fraction, Ratio of GFR to renal plasma flow, %
Measured: 195 mins
Renal oxygen supply/demand relationship
Renal oxygen consumption compared to renal oxygen delivery (CaO2-CrvO2/CaO2).
Measured: 195 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study startMay 2011
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenny Skytte Larsson, Sahlgrenska University Hospital
- Investigators
- Sven-Erik Ricksten, Professor, Study chair, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02453425
- Sponsor's protocol ID
- Sepsis-studien
- Status last verified
- Apr 2017
- First submitted
- 23 Apr 2015
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal Directed Therapy in Septic Shock - the Effects of Mean Arterial Pressure Levels, Adjusted With Norepinephrine, on Renal Perfusion, Function and Oxygenation.
- ClinicalTrials.gov ID
- NCT02453425
- Acronym / sponsor ID
- Sepsis-studien
- Conditions
- Septic Shock, Acute Kidney Injury
- Keywords
- renal blood flow, renal oxygenation, glomerular filtration rate, filtration fraction, blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 25 May 2015 (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 is to evaluate renal effects of 3 different levels of mean arterial pressure in early case of septic shock. In 8 patients diagnosed with early septic shock, we will adjust mean arterial pressure (MAP) to three different levels, using norepinephrine. At each level of MAP, central and renal hemodynamics and oxygenation states will be measured. Analysis will be made to describe the pathophysiology at MAP 75 mmHg, and then to evaluate at which MAP renal function and oxygenation is least affected negatively.
Detailed description
It is under debate what level of mean arterial pressure is the most appropriate for organ perfusion in septic shock. The kidneys are usually used for end-organ evaluation of appropriate perfusion and appropriate blood pressure level. What "adequate blood pressure" means is today unclear.
The purpose of this study is to chart the renal perfusion, oxygenation and function, and moreover to evaluate renal effects of 3 different levels of mean arterial pressure, in early phase of septic shock.
Patients will be included within the first 24 hrs after admission to the ICU diagnosed with septic shock. The patients will be sedated, mechanically ventilated and in need for norepinephrine for adequate blood pressure levels.
After 60 mins of steady state at MAP 75 mmHg, norepinephrine will be adjusted achieve MAP of 60 and 90 mmHg respectively, MAP being held at each level for 30 mins. At the end of each 30 mins period, central and renal hemodynamics will be measured, blood and urine samples will be collected.
Central hemodynamics will be measured by, and blood samples collected via a pulmonary catheter and an arterial line.
Renal hemodynamics will be measured using a renal vein catheter for retrograde thermodilution giving at hand renal blood flow (RBF), renal vein blood samples and urine collection provides extraction of Cr-EDTA for filtration fraction (FF) and glomerular filtration rate (GFR), renal oxygen consumption, and renal oxygen extraction as a measure of balance between renal oxygen delivery and consumption.
Via renal vein catheterisation and retrograde thermodilution, the study group have the unique possibility to actually evaluate renal blood flow, renal oxygenation and renal function in humans in vivo.
After finishing the data collection, analysis will be made to answer the question: which MAP is the most optimal concerning RBF, GFR and renal oxygenation in patients with septic shock?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 60 mmHg | Active comparator | Other: MAP 60 mmHgNorepinephrine adjusted to reach MAP 60 mmHg |
| 75 mmHg | Active comparator | Other: MAP 75 mmHgNorepinephrine adjusted to reach MAP 75 mmHg |
| 90 mmHg | Active comparator | Other: MAP 90 mmHgNorepinephrine adjusted to reach MAP 90 mmHg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- stable septic shock
- normovolemic
- norepinephrine
- intubated/ventilated
- normal s-creatinine according to local laboratory regards.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| MAP 60 mmHgAlso: NorepinephrineNorepinephrine adjusted to reach MAP 60 mmHg | Other | 60 mmHg |
| MAP 75 mmHgAlso: NorepinephrineNorepinephrine adjusted to reach MAP 75 mmHg | Other | 75 mmHg |
| MAP 90 mmHgAlso: NorepinephrineNorepinephrine adjusted to reach MAP 90 mmHg | Other | 90 mmHg |
Primary outcome
Glomerular filtration rate (GFR)
Time frame: 195 min
Renal function, ml/min
4 secondary outcomes
Renal Blood Flow (RBF)
Time frame: 195 mins
Renal Oxygen consumption
Time frame: 195 mins
Filtration fraction
Time frame: 195 mins
Renal oxygen supply/demand relationship
Time frame: 195 min
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 25 Apr 2017.
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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.
Sven-Erik Ricksten, Professor study chair
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAP 60 mmHg, MAP 75 mmHg and MAP 90 mmHg in people with Septic Shock and Acute Kidney Injury, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 0 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 25 Apr 2017. 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 Sweden. 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?
Glomerular filtration rate (GFR) (time frame: 195 min). 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 25 Apr 2017.