NCT02453425

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 25, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

5.8 years

First QC Date

April 23, 2015

Last Update Submit

April 24, 2017

Conditions

Septic ShockAcute Kidney Injury

Keywords

renal blood flowrenal oxygenationglomerular filtration ratefiltration fractionblood pressure

Outcome Measures

Primary Outcomes (1)

  • Glomerular filtration rate (GFR)

    Renal function, ml/min

    195 min

Secondary Outcomes (4)

  • Renal Blood Flow (RBF)

    195 mins

  • Renal Oxygen consumption

    195 mins

  • Filtration fraction

    195 mins

  • Renal oxygen supply/demand relationship

    195 min

Study Arms (3)

60 mmHg

ACTIVE COMPARATOR

Norepinephrine adjusted to reach MAP 60 mmHg

Other: MAP 60 mmHg

75 mmHg

ACTIVE COMPARATOR

Norepinephrine adjusted to reach MAP 75 mmHg

Other: MAP 75 mmHg

90 mmHg

ACTIVE COMPARATOR

Norepinephrine adjusted to reach MAP 90 mmHg

Other: MAP 90 mmHg

Interventions

MAP 60 mmHgOTHER

Norepinephrine adjusted to reach MAP 60 mmHg

Also known as: Norepinephrine
60 mmHg
MAP 75 mmHgOTHER

Norepinephrine adjusted to reach MAP 75 mmHg

Also known as: Norepinephrine
75 mmHg
MAP 90 mmHgOTHER

Norepinephrine adjusted to reach MAP 90 mmHg

Also known as: Norepinephrine
90 mmHg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital, dpt of anesthesiology and intensive care

Gothenburg, VGR, 41345, Sweden

Location

MeSH Terms

Conditions

Shock, SepticAcute Kidney Injury

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShockRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Sven-Erik Ricksten, Professor

    Sahlgrenska University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 23, 2015

First Posted

May 25, 2015

Study Start

May 1, 2011

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

April 25, 2017

Record last verified: 2017-04

Locations

SE(1)