Restriction of Intravenous Fluid in ICU Patients with Septic Shock.

Administration, Intravenous Adult Critical Care / methods Fluid Therapy / adverse effects Humans Intensive Care Units Shock, Septic / mortality

Journal

The New England journal of medicine

ISSN: 1533-4406

Titre abrégé: N Engl J Med

Pays: United States

ID NLM: 0255562

Informations de publication

Date de publication:
30 06 2022

Historique:

pubmed: 17 6 2022

medline: 2 7 2022

entrez: 16 6 2022

Statut: ppublish

Résumé

Intravenous fluids are recommended for the treatment of patients who are in septic shock, but higher fluid volumes have been associated with harm in patients who are in the intensive care unit (ICU). In this international, randomized trial, we assigned patients with septic shock in the ICU who had received at least 1 liter of intravenous fluid to receive restricted intravenous fluid or standard intravenous fluid therapy; patients were included if the onset of shock had been within 12 hours before screening. The primary outcome was death from any cause within 90 days after randomization. We enrolled 1554 patients; 770 were assigned to the restrictive-fluid group and 784 to the standard-fluid group. Primary outcome data were available for 1545 patients (99.4%). In the ICU, the restrictive-fluid group received a median of 1798 ml of intravenous fluid (interquartile range, 500 to 4366); the standard-fluid group received a median of 3811 ml (interquartile range, 1861 to 6762). At 90 days, death had occurred in 323 of 764 patients (42.3%) in the restrictive-fluid group, as compared with 329 of 781 patients (42.1%) in the standard-fluid group (adjusted absolute difference, 0.1 percentage points; 95% confidence interval [CI], -4.7 to 4.9; P = 0.96). In the ICU, serious adverse events occurred at least once in 221 of 751 patients (29.4%) in the restrictive-fluid group and in 238 of 772 patients (30.8%) in the standard-fluid group (adjusted absolute difference, -1.7 percentage points; 99% CI, -7.7 to 4.3). At 90 days after randomization, the numbers of days alive without life support and days alive and out of the hospital were similar in the two groups. Among adult patients with septic shock in the ICU, intravenous fluid restriction did not result in fewer deaths at 90 days than standard intravenous fluid therapy. (Funded by the Novo Nordisk Foundation and others; CLASSIC ClinicalTrials.gov number, NCT03668236.).

Sections du résumé

BACKGROUND

Intravenous fluids are recommended for the treatment of patients who are in septic shock, but higher fluid volumes have been associated with harm in patients who are in the intensive care unit (ICU).

METHODS

In this international, randomized trial, we assigned patients with septic shock in the ICU who had received at least 1 liter of intravenous fluid to receive restricted intravenous fluid or standard intravenous fluid therapy; patients were included if the onset of shock had been within 12 hours before screening. The primary outcome was death from any cause within 90 days after randomization.

RESULTS

We enrolled 1554 patients; 770 were assigned to the restrictive-fluid group and 784 to the standard-fluid group. Primary outcome data were available for 1545 patients (99.4%). In the ICU, the restrictive-fluid group received a median of 1798 ml of intravenous fluid (interquartile range, 500 to 4366); the standard-fluid group received a median of 3811 ml (interquartile range, 1861 to 6762). At 90 days, death had occurred in 323 of 764 patients (42.3%) in the restrictive-fluid group, as compared with 329 of 781 patients (42.1%) in the standard-fluid group (adjusted absolute difference, 0.1 percentage points; 95% confidence interval [CI], -4.7 to 4.9; P = 0.96). In the ICU, serious adverse events occurred at least once in 221 of 751 patients (29.4%) in the restrictive-fluid group and in 238 of 772 patients (30.8%) in the standard-fluid group (adjusted absolute difference, -1.7 percentage points; 99% CI, -7.7 to 4.3). At 90 days after randomization, the numbers of days alive without life support and days alive and out of the hospital were similar in the two groups.

CONCLUSIONS

Among adult patients with septic shock in the ICU, intravenous fluid restriction did not result in fewer deaths at 90 days than standard intravenous fluid therapy. (Funded by the Novo Nordisk Foundation and others; CLASSIC ClinicalTrials.gov number, NCT03668236.).

Identifiants

DOI: 10.1056/NEJMoa2202707 PMID: 35709019

pubmed: 35709019

doi: 10.1056/NEJMoa2202707

doi:

Banques de données

ClinicalTrials.gov

['NCT03668236']

Types de publication

Comparative Study Journal Article Multicenter Study Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

Pagination

2459-2470

Subventions

Organisme : Novo Nordisk Fonden

ID : NNF17OC0028608

Investigateurs

M Malbrain (M)

G Opdenacker (G)

M Nalos (M)

J Radêj (J)

M Kříž (M)

K Balihar (K)

M Harazim (M)

J Horák (J)

E Huňková (E)

K Jánská (K)

T Karvunidis (T)

J Kašpárek (J)

M Královcová (M)

D Lokingová (D)

M Matějovič (M)

S Pavlová (S)

B S Rasmussen (BS)

S R Aagaard (SR)

R M Siegumfeldt (RM)

S R Vestergaard (SR)

C S Meyhoff (CS)

S K L Hoffmann (SKL)

A Bastiansen (A)

L B Kiel (LB)

M C K Hansen (MCK)

D B Jensen (DB)

K M Sørensen (KM)

M L Rasmussen (ML)

L F Mahler (LF)

M Krag (M)

M K G Denneborg (MKG)

A C Brøchner (AC)

C F Elvander (CF)

M H Bestle (MH)

M Schønemann-Lund (M)

L Valbjørn (L)

S Lauritzen (S)

M L Vang (ML)

D F Jensen (DF)

H Bundgaard (H)

T S Meyhoff (TS)

M H Møller (MH)

A Perner (A)

P Sivapalan (P)

M N Kjær (MN)

P B Hjortrup (PB)

T S Jensen (TS)

C J S Hjortsø (CJS)

N D Meier (ND)

A B Jonsson (AB)

M Q Jensen (MQ)

G Vesterlund (G)

K R Uhre (KR)

J F Degn (JF)

A L S Lindegaard (ALS)

C M Olsen (CM)

C R L Bruun (CRL)

M O Collet (MO)

C T Anthon (CT)

K L Ellekjær (KL)

M Wetterslev (M)

A Granholm (A)

M W Munch (MW)

S Marker (S)

H C Thorsen-Meyer (HC)

C G Sølling (CG)

S K Pedersen (SK)

K K Knudsen (KK)

T S Straarup (TS)

L Nebrich (L)

L M Poulsen (LM)

N C Andersen-Ranberg (NC)

J V Jensen (JV)

N A Joseph (NA)

L S Herløv (LS)

S Weihe (S)

E Stormholt (E)

K La Cour (K)

J Laigaard (J)

E K Jensen (EK)

S F Caspersen (SF)

C Bekker (C)

K Olesen (K)

K Køppen (K)

L Russell (L)

T Hildebrandt (T)

V Pettilä (V)

M Bäcklund (M)

J Heinonen (J)

E Lappi (E)

S Bendel (S)

M Lång (M)

S Rahikainen (S)

E Halonen (E)

E Vaskelainen (E)

S Julkunen (S)

A Donati (A)

A Carsetti (A)

E Casarotta (E)

G Albano (G)

B Mazzola (B)

M Mazzoni (M)

S Celotti (S)

E Barbara (E)

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M Cecconi (M)

M Greco (M)

R Aceto (R)

M Ferrari (M)

M Vanoni (M)

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K Strand (K)

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J Haugen (J)

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B Johnstad (B)

Y K Martin (YK)

F F Friberg (FF)

H Seter (H)

C Ahlstedt (C)

K Kilsand (K)

M Cronhjort (M)

E Joelsson-Alm (E)

J Christensen (J)

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J Mårtensson (J)

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J Wilton (J)

J Hollenberg (J)

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M Hedberg (M)

M Wistrand (M)

M Yang (M)

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C Carlswärd (C)

S Fahoum (S)

M Siegemund (M)

A Hollinger (A)

N Zellweger (N)

S Abdelhamid (S)

H Fehlberg (H)

A Dietz (A)

M L Hauser (ML)

U Wenger (U)

S M Jakob (SM)

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J C Schefold (JC)

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