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Relation Between Mean Arterial Pressure and Renal Resistive Index in the Early Phase of Septic Shock (SEPSIR)

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ClinicalTrials.gov Identifier: NCT04281277
Recruitment Status : Not yet recruiting
First Posted : February 24, 2020
Last Update Posted : March 11, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Brief Summary:
This study evaluates if improvement of renal resistive index when mean arterial pressure increase (at 65 mmHg to 85 mmHg) in early phase of septic shock is predictive of better renal survival.

Condition or disease Intervention/treatment Phase
Septic Shock Device: increase of mean arterial pressure at 80-85 mmHg. Device: increase of mean arterial pressure at 65-70 mmHg. Not Applicable

Detailed Description:

Learned societes (survival sepsis campaign and ESICM) are currently recommending a mean arterial pressure (MAP) target at 65 mmHg in septic shoc with a potential increase to 85 mmHg in patients with medical history of arterial hypertension.

A high renal resistive index on the first day of septic shock was associated with acute renal failure more frequently on the 5th day. A decrease in the renal resistance index was also objectified during the increase in MAP.

The main objective of this trial is to study the relationship between the improvement of the resistance index during a test of increase in average blood pressure during septic shock and the improvement of renal function

In this interventional monocenter trial, we will measure the renal resistive index after stabilization of the MAP at 65 mmHg for two hours, then after 2 hours of stabilization at 85 mmHg. This part allows us to define the patients "responding" to the renal resistive index (improvement of the resitive renal index when the MAP increases).

Then, patients will be randomized into two groups :

  • first group with a MAP target at 65 mmHg
  • second group with a MAP target at 85 mmHg. There will be a stratification on the responder character to the renal resistance index.

Finally, we will assess renal function on the 7th day (with the assessment of serum creatinine and the change of stage of the KDIGO classification)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Relation Between Mean Arterial Pressure and Renal Resistive Index in the Early Phase of Septic Shock
Estimated Study Start Date : March 12, 2020
Estimated Primary Completion Date : January 15, 2021
Estimated Study Completion Date : March 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Active Comparator: low target group

target of mean arterial pressure(MAP) at 65-70 mmHg.

The therapeutic means used to obtain the MAP objectives within each group (increase in catecholamines and / or volume expansion) are left to the discretion of the clinician, in accordance with the recommendations.

Device: increase of mean arterial pressure at 65-70 mmHg.
increase of mean arterial pressure at 65-70 mmHg (with catecholamines or volemic expansion).

Experimental: high target group

target of mean arterial pressure (MAP) at 80-85 mmHg.

The therapeutic means used to obtain the MAP objectives within each group (increase in catecholamines and / or volume expansion) are left to the discretion of the clinician, in accordance with the recommendations.

Device: increase of mean arterial pressure at 80-85 mmHg.
increase of mean arterial pressure at 80-85 mmHg (with catecholamines or volemic expansion).




Primary Outcome Measures :
  1. changes of KDIGO stage [ Time Frame: Inclusion and day 7 ]
    modification of the KDIGO classification stage (estimated based on serum creatinine and diuresis) between the group with low target of mean arterial pressure ( 65-70 mmHg) and high target MAP (80-85 mmHg)


Secondary Outcome Measures :
  1. Renal resistive index [ Time Frame: Inclusion, and 2 hours of mean arterial pressure stabilized at 85 mmHg and every day (day 1 to day 7) ]
    We will assess the evolution of the renal resistive index during an increase in the target of MAP in the early phase of septic shock . We will assess the evolution of renal resistive index according to the comorbidities, as a function of time in septic shock, according to the hemodynamic data, according to quantity of filling solution administered and catecholamine doses

  2. Pulse wave speed indexed to size measure by popmetre (unit = m/s) [ Time Frame: Inclusion and 2 hours of mean arterial pressure stabilized at 85 mmH, and every day (day 1 to day 7) ]
    We will assess the correlation between variation in resistive renal index and arterial stifness (represented by the speed of the index- finger pulse wave measured by pOpmetre)

  3. Transit time measure by popmetre (unit = second ) [ Time Frame: Inclusion and 2 hours of mean arterial pressure stabilized at 85 mmH, and every day (day 1 to day 7) ]
    We will assess the correlation between variation in resistive renal index and arterial stifness (represented by the speed of the index- finger pulse wave measured by pOpmetre)

  4. Collection of all adverse event [ Time Frame: Day 1 to day 7 ]
    Difference in sides effects between target at 65-70 mmHg of MAP and 80-85 mmHg.

  5. amount of fluids (unit = L or L/day) [ Time Frame: Inclusion, day 1 to day 7 ]
  6. catecholamines free days [ Time Frame: day 1 to day 7 ]
  7. extra renal replacement free days [ Time Frame: Daily to day 1 to day 7, at day 28 and day 90 ]
    Difference in need of renal replacement therapy between the group of 80-85mmHg and the groupe 65-70 mmHg, depending on the responder character

  8. Number of day with supportive care in intensive care unit (renal replacement therapy, mechanical ventilation, extracorporeal membrane oxygenation) [ Time Frame: Collection daily between Day 1 and Day 7, at Day 28. ]
    Quantification of the number of days with supportive care (catecholamine,renal replacement therapy, mechanical ventilation, extracorporeal membrane oxygenation)

  9. Number of day in intensive care unit [ Time Frame: Collection at Day 28 and Day 90 ]
    Quantification of the number of days hospitalized in intensive care unit

  10. Number of day in hospital [ Time Frame: Collection at Day 28 and Day 90 ]
    Quantification of the number of days hospitalized.

  11. hemodynamic data collected by swan ganz or PICCO catheter [ Time Frame: Inclusion and at 2 hours, daily between Day 1 and Day 7 ]
  12. quantity of nephrotoxic drugs [ Time Frame: Inclusion and daily between Day 1 and Day 7. ]
  13. serum creatinine (unit = µmol/L) [ Time Frame: Inclusion and daily between Day 1 and Day 7 ]
  14. Diuresis (unit = mL per day) [ Time Frame: Daily between day 1 and day 7 ]
  15. Survival at day 28 [ Time Frame: patient status (live or dead) at day 28 ]
  16. Survival at day 90 [ Time Frame: patient status (live or dead) at day 90 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients (≥ 18 ans)
  • Admitted to the intensive care unit of Angers with
  • arterial hypotension requiring the etablishment of catecholamines
  • In a context of proven or suspected sepsis, whaterver the cause of this infection.
  • Invasive cardiac output monitoring device in place.
  • After 2 hours of stabilization at 65 mmHg of mean arterial pressure

Exclusion Criteria:

  • Pre-existing chronic renal failure (glomerular filtration rate < 60 mL/min with MDRD)
  • Solitary kidney (anatomical or functional)
  • History of united or bilateral stenosis of the renal arteries
  • decision to stop or limit treatment
  • patient with an emergency indication of renal replacement therapy (severe hyperkalemia, severe metabolical acidosis with pH <7.15, acute pulmonary edema due to fluid overload resulting in severe hypoxemia, serum urea concentration > 40 mmol/l and oliguria/anuria > 72 h.)
  • pregnant, lactating or parturient woman
  • patient deprived of liberty by judicial or administrative decision
  • patient with psychiatric compulsory care
  • patient subject to legal protection measures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04281277


Contacts
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Contact: Nicolas FAGE, Resident 0241355865 fage.nicolas@gmail.com

Locations
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France
CHU Angers. Médecine Intensive Réanimation et médecine hyperbare
Angers, France, 49100
Contact: Nicolas FAGE, resident       fage.nicolas@gmail.com   
Principal Investigator: Pierre ASFAR, MD PHD         
Sponsors and Collaborators
University Hospital, Angers
Investigators
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Principal Investigator: Pierre ASFAR, MD PHD University Hospital, Angers

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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT04281277    
Other Study ID Numbers: 49RC19_0236
First Posted: February 24, 2020    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University Hospital, Angers:
renal resistive index
mean arterial pressure
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation