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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

Tracking Information
First Submitted Date  ICMJE April 23, 2015
First Posted Date  ICMJE May 25, 2015
Last Update Posted Date April 25, 2017
Study Start Date  ICMJE May 2011
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2017)
Glomerular filtration rate (GFR) [ Time Frame: 195 min ]
Renal function, ml/min
Original Primary Outcome Measures  ICMJE
 (submitted: May 20, 2015)
Glomerular filtration rate (GFR) [ Time Frame: 195 min ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2017)
  • Renal Blood Flow (RBF) [ Time Frame: 195 mins ]
    ml/min
  • Renal Oxygen consumption [ Time Frame: 195 mins ]
    ml/min
  • 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, %
  • Renal oxygen supply/demand relationship [ Time Frame: 195 min ]
    Renal oxygen consumption compared to renal oxygen delivery (CaO2-CrvO2/CaO2).
Original Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2015)
  • Renal Blood Flow (RBF) [ Time Frame: 195 mins ]
    ml/min
  • Renal Oxygen consumption [ Time Frame: 195 mins ]
    ml/min
  • Filtration fraction [ Time Frame: 195 mins ]
  • Renal oxygen supply/demand relationship [ Time Frame: 195 min ]
    Renal oxygen consumption compared to renal oxygen delivery (CaO2-CrvO2/CaO2).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Blood Pressure on Renal Function and Oxygenation in Septic Shock
Official Title  ICMJE Goal Directed Therapy in Septic Shock - the Effects of Mean Arterial Pressure Levels, Adjusted With Norepinephrine, on Renal Perfusion, Function and Oxygenation.
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Septic Shock
  • Acute Kidney Injury
Intervention  ICMJE
  • Other: MAP 60 mmHg
    Norepinephrine adjusted to reach MAP 60 mmHg
    Other Name: Norepinephrine
  • Other: MAP 75 mmHg
    Norepinephrine adjusted to reach MAP 75 mmHg
    Other Name: Norepinephrine
  • Other: MAP 90 mmHg
    Norepinephrine adjusted to reach MAP 90 mmHg
    Other Name: Norepinephrine
Study Arms  ICMJE
  • Active Comparator: 60 mmHg
    Norepinephrine adjusted to reach MAP 60 mmHg
    Intervention: Other: MAP 60 mmHg
  • Active Comparator: 75 mmHg
    Norepinephrine adjusted to reach MAP 75 mmHg
    Intervention: Other: MAP 75 mmHg
  • Active Comparator: 90 mmHg
    Norepinephrine adjusted to reach MAP 90 mmHg
    Intervention: Other: MAP 90 mmHg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 20, 2015)
8
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • stable septic shock
  • normovolemic
  • norepinephrine
  • intubated/ventilated
  • normal s-creatinine according to local laboratory regards.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02453425
Other Study ID Numbers  ICMJE Sepsis-studien
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Jenny Skytte Larsson, Sahlgrenska University Hospital, Sweden
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sahlgrenska University Hospital, Sweden
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Sven-Erik Ricksten, Professor Sahlgrenska University Hospital, Sweden
PRS Account Sahlgrenska University Hospital, Sweden
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP