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

Primary Purpose

Septic Shock, Acute Kidney Injury

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
MAP 60 mmHg
MAP 75 mmHg
MAP 90 mmHg
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Septic Shock focused on measuring renal blood flow, renal oxygenation, glomerular filtration rate, filtration fraction, blood pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • Sahlgrenska University Hospital, dpt of anesthesiology and intensive care

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

60 mmHg

75 mmHg

90 mmHg

Arm Description

Norepinephrine adjusted to reach MAP 60 mmHg

Norepinephrine adjusted to reach MAP 75 mmHg

Norepinephrine adjusted to reach MAP 90 mmHg

Outcomes

Primary Outcome Measures

Glomerular filtration rate (GFR)
Renal function, ml/min

Secondary Outcome Measures

Renal Blood Flow (RBF)
ml/min
Renal Oxygen consumption
ml/min
Filtration fraction
glomerular filtration rate (GFR) to the renal plasma flow (RPF). Filtration Fraction, Ratio of GFR to renal plasma flow, %
Renal oxygen supply/demand relationship
Renal oxygen consumption compared to renal oxygen delivery (CaO2-CrvO2/CaO2).

Full Information

First Posted
April 23, 2015
Last Updated
April 24, 2017
Sponsor
Sahlgrenska University Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT02453425
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden

4. Oversight

Data Monitoring Committee
No

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock, Acute Kidney Injury
Keywords
renal blood flow, renal oxygenation, glomerular filtration rate, filtration fraction, blood pressure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
60 mmHg
Arm Type
Active Comparator
Arm Description
Norepinephrine adjusted to reach MAP 60 mmHg
Arm Title
75 mmHg
Arm Type
Active Comparator
Arm Description
Norepinephrine adjusted to reach MAP 75 mmHg
Arm Title
90 mmHg
Arm Type
Active Comparator
Arm Description
Norepinephrine adjusted to reach MAP 90 mmHg
Intervention Type
Other
Intervention Name(s)
MAP 60 mmHg
Other Intervention Name(s)
Norepinephrine
Intervention Description
Norepinephrine adjusted to reach MAP 60 mmHg
Intervention Type
Other
Intervention Name(s)
MAP 75 mmHg
Other Intervention Name(s)
Norepinephrine
Intervention Description
Norepinephrine adjusted to reach MAP 75 mmHg
Intervention Type
Other
Intervention Name(s)
MAP 90 mmHg
Other Intervention Name(s)
Norepinephrine
Intervention Description
Norepinephrine adjusted to reach MAP 90 mmHg
Primary Outcome Measure Information:
Title
Glomerular filtration rate (GFR)
Description
Renal function, ml/min
Time Frame
195 min
Secondary Outcome Measure Information:
Title
Renal Blood Flow (RBF)
Description
ml/min
Time Frame
195 mins
Title
Renal Oxygen consumption
Description
ml/min
Time Frame
195 mins
Title
Filtration fraction
Description
glomerular filtration rate (GFR) to the renal plasma flow (RPF). Filtration Fraction, Ratio of GFR to renal plasma flow, %
Time Frame
195 mins
Title
Renal oxygen supply/demand relationship
Description
Renal oxygen consumption compared to renal oxygen delivery (CaO2-CrvO2/CaO2).
Time Frame
195 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: stable septic shock normovolemic norepinephrine intubated/ventilated normal s-creatinine according to local laboratory regards.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven-Erik Ricksten, Professor
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Study Chair
Facility Information:
Facility Name
Sahlgrenska University Hospital, dpt of anesthesiology and intensive care
City
Göteborg
State/Province
VGR
ZIP/Postal Code
41345
Country
Sweden

12. IPD Sharing Statement

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

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