We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effects of Blood Pressure on Renal Function and Oxygenation in Septic Shock

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02453425
Recruitment Status : Completed
First Posted : May 25, 2015
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Jenny Skytte Larsson, Sahlgrenska University Hospital, Sweden

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Septic Shock Acute Kidney Injury Other: MAP 60 mmHg Other: MAP 75 mmHg Other: MAP 90 mmHg Not Applicable

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?

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Goal Directed Therapy in Septic Shock - the Effects of Mean Arterial Pressure Levels, Adjusted With Norepinephrine, on Renal Perfusion, Function and Oxygenation.
Study Start Date : May 2011
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests Shock

Arm Intervention/treatment
Active Comparator: 60 mmHg
Norepinephrine adjusted to reach MAP 60 mmHg
Other: MAP 60 mmHg
Norepinephrine adjusted to reach MAP 60 mmHg
Other Name: Norepinephrine

Active Comparator: 75 mmHg
Norepinephrine adjusted to reach MAP 75 mmHg
Other: MAP 75 mmHg
Norepinephrine adjusted to reach MAP 75 mmHg
Other Name: Norepinephrine

Active Comparator: 90 mmHg
Norepinephrine adjusted to reach MAP 90 mmHg
Other: MAP 90 mmHg
Norepinephrine adjusted to reach MAP 90 mmHg
Other Name: Norepinephrine




Primary Outcome Measures :
  1. Glomerular filtration rate (GFR) [ Time Frame: 195 min ]
    Renal function, ml/min


Secondary Outcome Measures :
  1. Renal Blood Flow (RBF) [ Time Frame: 195 mins ]
    ml/min

  2. Renal Oxygen consumption [ Time Frame: 195 mins ]
    ml/min

  3. Filtration fraction [ Time Frame: 195 mins ]
    glomerular filtration rate (GFR) to the renal plasma flow (RPF). Filtration Fraction, Ratio of GFR to renal plasma flow, %

  4. Renal oxygen supply/demand relationship [ Time Frame: 195 min ]
    Renal oxygen consumption compared to renal oxygen delivery (CaO2-CrvO2/CaO2).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • stable septic shock
  • normovolemic
  • norepinephrine
  • intubated/ventilated
  • normal s-creatinine according to local laboratory regards.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02453425


Locations
Layout table for location information
Sweden
Sahlgrenska University Hospital, dpt of anesthesiology and intensive care
Göteborg, VGR, Sweden, 41345
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
Layout table for investigator information
Study Chair: Sven-Erik Ricksten, Professor Sahlgrenska University Hospital, Sweden
Layout table for additonal information
Responsible Party: Jenny Skytte Larsson, MD, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT02453425    
Other Study ID Numbers: Sepsis-studien
First Posted: May 25, 2015    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Keywords provided by Jenny Skytte Larsson, Sahlgrenska University Hospital, Sweden:
renal blood flow
renal oxygenation
glomerular filtration rate
filtration fraction
blood pressure
Additional relevant MeSH terms:
Layout table for MeSH terms
Shock, Septic
Acute Kidney Injury
Shock
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Sepsis
Infections
Systemic Inflammatory Response Syndrome
Inflammation
Norepinephrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents