Septic ShockNCT00197886
Dose of Norepinephrine and the Concentration of L-Lactate in the Rectum and Stomach in Patients With Septic Shock.
A study testing Changing dose of norepinephrine and blood pressure in people with Septic Shock, run by Herlev Hospital at 1 site in Denmark.
Trial summary
Norepinephrine is a drug used to increase blood pressure in patients with life-threatening infection. However, norepinephrine may limit the bloodflow to the gut, thereby causing relative lack of oxygen to the cells. This leads to increased formation of lactic acid. 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?
- Changing dose of norepinephrine and blood pressure
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2004to Dec 2005
- 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
- Septic shock
- NE-dose > 0.1 microg/kg/min
- CI > 3.0 l/min/m2
Who cannot join
- Age < 18, unable to obtain informed consent from relatives
- Untreated hypertension
- Pregnancy
- Pathology in the rectum or stomach
- Limitation of therapy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of Intensive Care, Herlev University Hospital
Herlev, 2730
About this study
Norepinephrine is a drug used to increase blood pressure in patients with life-threatening infection. However, norepinephrine may limit the bloodflow to the gut, thereby causing relative lack of oxygen to the cells. This leads to increased formation of lactic acid.
This study examines whether increasing the dose of norepinephrine leads to higher concentrations of lactic acid in the rectum and stomach in patients with life-threatening infection.
- Conditions
- Septic Shock
- Being tested
- Changing dose of norepinephrine and blood pressure
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Changing dose of norepinephrine and blood pressureDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
L-lactate concentration in the rectum and stomach.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startOct 2004
- Study completionDec 2005
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Anders Perner, MD,PhD, Study chair, Dept. of Anaesthesia and Intensive Care, Herlev University Hospital, DK-2730 Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00197886
- Sponsor's protocol ID
- 2004-7041-20
- Status last verified
- Sep 2006
- First submitted
- 14 Sep 2005
- Last updated
- 20 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose of Norepinephrine and the Concentration of L-Lactate in the Rectum and Stomach in Patients With Septic Shock.
- ClinicalTrials.gov ID
- NCT00197886
- Acronym / sponsor ID
- 2004-7041-20
- Conditions
- Septic Shock
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Oct 2004
- Study completion
- Dec 2005
- First posted
- 20 Sep 2005 (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.
Norepinephrine is a drug used to increase blood pressure in patients with life-threatening infection. However, norepinephrine may limit the bloodflow to the gut, thereby causing relative lack of oxygen to the cells. This leads to increased formation of lactic acid.
This study examines whether increasing the dose of norepinephrine leads to higher concentrations of lactic acid in the rectum and stomach in patients with life-threatening infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Septic shock
- NE-dose > 0.1 microg/kg/min
- CI > 3.0 l/min/m2
Key exclusion criteria (5 listed)
- Age < 18, unable to obtain informed consent from relatives
- Untreated hypertension
- Pregnancy
- Pathology in the rectum or stomach
- Limitation of therapy
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 |
|---|---|---|
| Changing dose of norepinephrine and blood pressure | Drug | – |
Primary outcome
L-lactate concentration in the rectum and stomach.
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 20 Sep 2006.
Related trials for Septic Shock
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
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.
Anders Perner, MD,PhD study chair
Dept. of Anaesthesia and Intensive Care, Herlev University Hospital, DK-2730 Herlev
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Changing dose of norepinephrine and blood pressure in people with Septic Shock, run by Herlev Hospital at 1 site in Denmark.
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 5 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 20 Sep 2006. 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 Denmark. 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?
L-lactate concentration in the rectum and stomach.. 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 20 Sep 2006.