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

Septic Shock Clinical Trial

— SEPSIR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04281277
• Other study ID #: 49RC19_0236
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2020
• Est. completion date: March 15, 2026

Study information

• Verified date: October 2022
• Source: University Hospital, Angers
• Contact: Nicolas FAGE, Resident
• Phone: 0241355865
• Email: fage.nicolas[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 15, 2026
• Est. primary completion date: January 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Device:
• increase of mean arterial pressure at 80-85 mmHg.
increase of mean arterial pressure at 80-85 mmHg (with catecholamines or volemic expansion).
• increase of mean arterial pressure at 65-70 mmHg.
increase of mean arterial pressure at 65-70 mmHg (with catecholamines or volemic expansion).

Locations

Country	Name	City	State
France	CHU Angers. Médecine Intensive Réanimation et médecine hyperbare	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes of KDIGO stage	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)	Inclusion and day 7
Secondary	Renal resistive index	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	Inclusion, and 2 hours of mean arterial pressure stabilized at 85 mmHg and every day (day 1 to day 7)
Secondary	Collection of all adverse event	Difference in sides effects between target at 65-70 mmHg of MAP and 80-85 mmHg.	Day 1 to day 7
Secondary	amount of fluids (unit = L or L/day)		Inclusion, day 1 to day 7
Secondary	catecholamines free days		day 1 to day 7
Secondary	extra renal replacement free days	Difference in need of renal replacement therapy between the group of 80-85mmHg and the groupe 65-70 mmHg, depending on the responder character	Daily to day 1 to day 7, at day 28 and day 90
Secondary	Number of day with supportive care in intensive care unit (renal replacement therapy, mechanical ventilation, extracorporeal membrane oxygenation)	Quantification of the number of days with supportive care (catecholamine,renal replacement therapy, mechanical ventilation, extracorporeal membrane oxygenation)	Collection daily between Day 1 and Day 7, at Day 28.
Secondary	Number of day in intensive care unit	Quantification of the number of days hospitalized in intensive care unit	Collection at Day 28 and Day 90
Secondary	Number of day in hospital	Quantification of the number of days hospitalized.	Collection at Day 28 and Day 90
Secondary	hemodynamic data collected by swan ganz or PICCO catheter		Inclusion and at 2 hours, daily between Day 1 and Day 7
Secondary	quantity of nephrotoxic drugs		Inclusion and daily between Day 1 and Day 7.
Secondary	serum creatinine (unit = µmol/L)		Inclusion and daily between Day 1 and Day 7
Secondary	Diuresis (unit = mL per day)		Daily between day 1 and day 7
Secondary	Survival at day 28		patient status (live or dead) at day 28
Secondary	Survival at day 90		patient status (live or dead) at day 90