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NCT Number: NCT04281277

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Angers. Médecine Intensive Réanimation et médecine hyperbare

Angers, 49100, France

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • norepinephrine dose ⩾ 0.1µg/kg/min
  • 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

Treatment and study plan

increase of mean arterial pressure at 80-85 mmHg.

Device

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

increase of mean arterial pressure at 65-70 mmHg.

Device

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

Primary outcomes

  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 outcomes

  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. 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.

  3. amount of fluids (unit = L or L/day)

    Time frame: Inclusion, day 1 to day 7

  4. catecholamines free days

    Time frame: day 1 to day 7

  5. 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

  6. 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)

  7. 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

  8. Number of day in hospital

    Time frame: Collection at Day 28 and Day 90

    Quantification of the number of days hospitalized.

  9. hemodynamic data collected by swan ganz or PICCO catheter

    Time frame: Inclusion and at 2 hours, daily between Day 1 and Day 7

  10. quantity of nephrotoxic drugs

    Time frame: Inclusion and daily between Day 1 and Day 7.

  11. serum creatinine (unit = µmol/L)

    Time frame: Inclusion and daily between Day 1 and Day 7

  12. Diuresis (unit = mL per day)

    Time frame: Daily between day 1 and day 7

  13. Survival at day 28

    Time frame: patient status (live or dead) at day 28

  14. Survival at day 90

    Time frame: patient status (live or dead) at day 90

  15. Skin recoloration time evolution

    Time frame: Inclusion and at 2 hours, daily between Day 1 and Day 7

    measurement onto the right index finger by a standardized method after 2 hours of stabilization at 65 mmHg and after 2 hours of stabilization at 85 mmHg.

  16. Skin recoloration time evolution

    Time frame: Inclusion and at 2 hours, daily between Day 1 and Day 7

    measurement onto the right index fingerby a standardized method depending on the randomization group.

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Acronym: SEPSIR

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Feb 24, 2020
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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