Evidence map›Paper›PMID 30630380›Full record

Trial reportJournal of intensive care medicine2020

Conservative Fluid Management After Sepsis Resuscitation: A Pilot Randomized Trial.

Matthew W Semler, David R Janz, Jonathan D Casey, Wesley H Self, Todd W Rice

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of intensive care medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02159079 (A Phase II/III Randomized Controlled Trial of a Conservative Fluid Balance Strategy for Patients With Sepsis and Cardiopulmonary Dysfunction), which is not on this map. Cited by 23 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 4 pooled it
1.8field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02159079 nacompletednot on this map

A Phase II/III Randomized Controlled Trial of a Conservative Fluid Balance Strategy for Patients With Sepsis and Cardiopulmonary Dysfunction

TypeinterventionalSponsorVanderbilt UniversityRan2014 to 2016Enrolled30ConditionsSepsisArmsConservative Fluid Management Strategy
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 4 syntheses or guidelines pooled it, 35 citations in OpenAlex.

  1. Guideline
  2. Guideline
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
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  13. The times are changing: A primer on novel clinical trial designs and endpoints in critical care research.American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists · 2024
    Article
  14. Article
  15. Review
  16. Article
  17. Review
  18. Evolving Management Practices for Early Sepsis-induced Hypoperfusion: A Narrative Review.American journal of respiratory and critical care medicine · 2023
    Review
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Matthew W SemlerDivision of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.ORCID https://orcid.org/0000-0002-7664-8263
David R JanzSection of Pulmonary/Critical Care & Allergy/Immunology, Louisiana State University School of Medicine, New Orleans, LA, USA.
Jonathan D CaseyDivision of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
Wesley H SelfDepartment of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
Todd W RiceDivision of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
Vanderbilt University Medical Center · USLouisiana State University · US

Funding

The Vanderbilt Institute for Clinical and Translational Research (VICTR)UL1TR000445 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI BERNARD, GORDON RAPHAEL · 2012 to 2016
$41.4M
Clinical and Translational Training Program in Pulmonary MedicineT32HL087738 · NHLBI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Lorraine B Ware · 2007 to 2026
$7.0M
Oxygen Saturation Targets during Mechanical Ventilation of Critically Ill Adults: A Clinical TrialK23HL143053 · NHLBI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI SEMLER, MATTHEW WALL · 2018 to 2022
$854k
Citrulline to Prevent or Mitigate Acute Lung Injury in Severe SepsisR34HL105869 · NHLBI · VANDERBILT UNIVERSITY · PI RICE, TODD W · 2012 to 2014
$686k
Salivary Cortisol as a Marker of Community-Acquired Pneumonia Severity in AdultsK23GM110469 · NIGMS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI SELF, WESLEY H · 2015 to 2018
$683k
NCATS NIH HHS UL1 TR000445NHLBI NIH HHS K23 HL143053NHLBI NIH HHS R34 HL105869NHLBI NIH HHS T32 HL087738NIGMS NIH HHS K23 GM110469
6 · The paper itself

Abstract

rationaleThe feasibility and clinical outcomes of conservative fluid management after sepsis resuscitation remain unknown.

objectivesTo evaluate the effect of a conservative fluid management protocol on fluid balance and intensive care unit (ICU)-free days among patients with sepsis.

methodsIn a single-center phase II/III randomized trial, we enrolled adults with suspected infection, ≥2 systemic inflammatory response syndrome criteria, and either shock (mean arterial pressure <60 mm Hg or vasopressors) or respiratory insufficiency (mechanical ventilation or oxygen saturation <97% and fraction of inspired oxygen ≥0.3). Patients were randomized 1:1 to usual care or a conservative fluid management protocol. The protocol restricted intravenous fluid administration during shock to treatment of oliguria or increasing vasopressor requirement. In the absence of shock, loop diuretic infusion targeted equal fluid input and output each study day. The primary outcomes were mean daily fluid balance (phase II) and ICU-free days (phase III).

resultsAt the completion of phase II (n = 30), the difference in mean daily fluid balance between groups (-398 mL) was less than the prespecified threshold (-500 mL) and the trial was stopped. Patients in the conservative fluid management (n = 15) and usual care (n = 15) groups experienced similar cumulative fluid input (8450 mL vs 7049 mL;

conclusionsIn this phase II trial, a conservative fluid management protocol did not decrease mean daily fluid balance by more than 500 mL among patients with sepsis. REGISTRATION: Clinicaltrials.gov; NCT02159079.

Indexed as

Fluid TherapySepsisAgedCrystalloid SolutionsFemaleHumansMaleMiddle AgedPilot ProjectsResuscitationCrystalloid Solutionsacute kidney injuryintravenous fluidsepsis

Identifiers

PMID30630380
PMCPMC6620161
OpenAlexW2909812503

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.