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

• ClinicalTrials.gov Identifier: NCT02453425
• Recruitment Status: Completed
• First Posted: May 25, 2015
• Last Update Posted: April 25, 2017
• Sponsor: Sahlgrenska University Hospital, Sweden
• Information provided by (Responsible Party): Jenny Skytte Larsson, Sahlgrenska University Hospital, Sweden

Tracking Information

• First Submitted Date: April 23, 2015
• First Posted Date: May 25, 2015
• Last Update Posted Date: April 25, 2017
• Study Start Date: May 2011
• Actual Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 24, 2017)

Glomerular filtration rate (GFR) [ Time Frame: 195 min ]

Renal function, ml/min

• Original Primary Outcome Measures (submitted: May 20, 2015): Glomerular filtration rate (GFR) [ Time Frame: 195 min ]

Current Secondary Outcome Measures (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 (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: The Effects of Blood Pressure on Renal Function and Oxygenation in Septic Shock
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Septic Shock
• Acute Kidney Injury

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 20, 2015): 8
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 2017
• Actual Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT02453425
• Other Study ID Numbers: Sepsis-studien
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Jenny Skytte Larsson, Sahlgrenska University Hospital, Sweden
• Original Responsible Party: Same as current
• Current Study Sponsor: Sahlgrenska University Hospital, Sweden
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Sven-Erik Ricksten, Professor; Sahlgrenska University Hospital, Sweden

• PRS Account: Sahlgrenska University Hospital, Sweden
• Verification Date: April 2017