Septic Shock
Conditions
Keywords
renal resistive index, mean arterial pressure
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.
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)
Interventions
DEVICEincrease of mean arterial pressure at 80-85 mmHg.
increase of mean arterial pressure at 80-85 mmHg (with catecholamines or volemic expansion).
DEVICEincrease of mean arterial pressure at 65-70 mmHg.
increase of mean arterial pressure at 65-70 mmHg (with catecholamines or volemic expansion).
Sponsors
University Hospital, Angers
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes of KDIGO stage | 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
| Measure | Time frame | Description |
|---|---|---|
| serum creatinine (unit = µmol/L) | Inclusion and daily between Day 1 and Day 7 | — |
| Diuresis (unit = mL per day) | Daily between day 1 and day 7 | — |
| Survival at day 28 | patient status (live or dead) at day 28 | — |
| Survival at day 90 | patient status (live or dead) at day 90 | — |
| Skin recoloration time evolution | 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. |
| hemodynamic data collected by swan ganz or PICCO catheter | Inclusion and at 2 hours, daily between Day 1 and Day 7 | — |
| Renal resistive index | 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 |
| Collection of all adverse event | Day 1 to day 7 | Difference in sides effects between target at 65-70 mmHg of MAP and 80-85 mmHg. |
| amount of fluids (unit = L or L/day) | Inclusion, day 1 to day 7 | — |
| catecholamines free days | day 1 to day 7 | — |
| extra renal replacement free days | 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 |
| Number of day with supportive care in intensive care unit (renal replacement therapy, mechanical ventilation, extracorporeal membrane oxygenation) | 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) |
| Number of day in intensive care unit | Collection at Day 28 and Day 90 | Quantification of the number of days hospitalized in intensive care unit |
| quantity of nephrotoxic drugs | Inclusion and daily between Day 1 and Day 7. | — |
| Number of day in hospital | Collection at Day 28 and Day 90 | Quantification of the number of days hospitalized. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORPierre ASFAR, MD PHD
University Hospital, Angers
Outcome results
None listed