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

Condition(s) targeted: Septic Shock; Acute Kidney Injury

Intervention: MAP 60 mmHg (Other); MAP 75 mmHg (Other); MAP 90 mmHg (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Sahlgrenska University Hospital, Sweden

Official(s) and/or principal investigator(s):
Sven-Erik Ricksten, Professor, Study Chair, Affiliation: Sahlgrenska University Hospital, Sweden

Overall contact:
Jenny Skytte Larsson, MD, Phone: 0046706964800, Email: jenny.skytte@vgregion.se

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 evaluate at which MAP renal function and oxygenation is least affected negatively.

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 design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Glomerular filtration rate (GFR)

Secondary outcome:

Renal Blood Flow (RBF)

Renal Oxygen consumption

Filtration fraction

Renal oxygen supply/demand relationship

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, and this is what we will evaluate in this study: The purpose of this study is 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. They must 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, we 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?

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- stable septic shock

- normovolemic

- norepinephrine

- intubated/ventilated

- normal s-creatinine according to local laboratory regards.

Jenny Skytte Larsson, MD, Phone: 0046706964800, Email: jenny.skytte@vgregion.se

Sahlgrenska University Hospital, dpt of anesthesiology and intensive care, Göteborg, VGR 41345, Sweden; Recruiting
Jenny Skytte Larsson, MD

Starting date: May 2011
Last updated: May 20, 2015