Utility of Sodium Lactate Infusion During Septic Shock

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-04

Study Completion Date

2023-02-21

Brief Summary

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ULIS-1 is an open-label pilot study concerning utility of molar sodium lactate in fluid balance in septic shock patients

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Detailed Description

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ULIS-1 consists in three arms of treatment during the first 24hrs of septic shock treatment.

* normal saline
* sodium lactate 2.5ml/kg in 60min then
* either 0.25 or 0.5ml/kg/h during 24hrs Main criteria is fluid balance at 48hrs

Conditions

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Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

bolus then continuous infusion of molar sodium lactate (2 doses) or normal saline

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Normal saline

at physician discretion

Group Type SHAM_COMPARATOR

Normal saline

Intervention Type DRUG

normal saline at physician discretion

Sodium lactate light dose

bolus 2.5ml/kg lactate 60min then 0.25ml/kg/h during 24hrs

Group Type EXPERIMENTAL

Sodium Lactate light dose

Intervention Type DRUG

bolus 2.5ml/kg then 0.25ml/kg/h

Sodium lactate high dose

bolus 2.5ml/kg lactate 60min then 0.50ml/kg/h during 24hrs

Group Type EXPERIMENTAL

Sodium Lactate high dose

Intervention Type DRUG

bolus 2.5ml/kg then 0.5ml/kg/h

Interventions

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Sodium Lactate light dose

bolus 2.5ml/kg then 0.25ml/kg/h

Intervention Type DRUG

Sodium Lactate high dose

bolus 2.5ml/kg then 0.5ml/kg/h

Intervention Type DRUG

Normal saline

normal saline at physician discretion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Presence of septic shock
* requiring vascular filling within 12 hours after introduction of Noradrenaline. Septic shock is defined as sepsis with persistent hypotension requiring the administration of vasopressors to maintain RTE \> 65mmHg.
* social insurance

Exclusion Criteria

* pregnancy
* cardiac arrest
* more than 50ml/kg of fluid loading
* chronic renal failure with chronic hemodialysis or the investigators estimate a need for renal replacement therapy in the following 24hrs
* child C or acute liver failure with PT\<40% (unless AVK)
* plasmatic sodium \<120 or \>145mmol/l
* metabolic alkalosis with pH\>7.45

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No