Evidence map›Paper›PMID 23601796›Full record

Trial reportCritical care (London, England)2013

Balanced versus chloride-rich solutions for fluid resuscitation in brain-injured patients: a randomised double-blind pilot study.

Antoine Roquilly, Olivier Loutrel, Raphael Cinotti, Elise Rosenczweig, Laurent Flet, Pierre Joachim Mahe, Romain Dumont, Anne Marie Chupin, Catherine Peneau, Corinne Lejus and 3 more

Registry-linked trialOpen access · goldAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Critical care (London, England), 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00847977 (Intérêt d'Utiliser Des solutés de Remplissage équilibrés à la Phase précoce d'un Traumatisme crânien Grave Pour Limiter l'Acidose hyperchlorémique), which is not on this map. Cited by 38 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 5 pooled it
5.5field-weighted citation impact, top 3% 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.

NCT00847977 phase3terminatednot on this map

Intérêt d'Utiliser Des solutés de Remplissage équilibrés à la Phase précoce d'un Traumatisme crânien Grave Pour Limiter l'Acidose hyperchlorémique

TypeinterventionalSponsorNantes University HospitalRan2008 to 2010Enrolled42ConditionsHead TraumaArmsuse of a non balced fluid and of a macromolecular fluid, use of balanced crystalloids fluid and macromolecular fluid
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 5 syntheses or guidelines pooled it, 107 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Guideline
  5. Guideline
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Article
  13. Review
  14. Review
  15. Review
  16. Review
  17. Article
  18. Article
  19. Acute kidney injury in neurocritical care.Critical care (London, England) · 2023
    Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 3 institutions in 1 country.

Antoine Roquilly
Olivier Loutrel
Raphael Cinotti
Elise Rosenczweig
Laurent Flet
Pierre Joachim Mahe
Romain Dumont
Anne Marie Chupin
Catherine Peneau
Corinne Lejus
Yvonnick Blanloeil
Christelle Volteau
Karim Asehnoune
Hôpital Laennec · FRCentre d'Investigation Clinique de Nantes · FRCentre Hospitalier Universitaire de Nantes · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionWe sought to investigate whether the use of balanced solutions reduces the incidence of hyperchloraemic acidosis without increasing the risk for intracranial hypertension in patients with severe brain injury.

methodsWe conducted a single-centre, two-arm, randomised, double-blind, pilot controlled trial in Nantes, France. Patients with severe traumatic brain injury (Glasgow Coma Scale score ≤8) or subarachnoid haemorrhage (World Federation of Neurosurgical Society grade III or higher) who were mechanically ventilated were randomised within the first 12 hours after brain injury to receive either isotonic balanced solutions (crystalloid and hydroxyethyl starch; balanced group) or isotonic sodium chloride solutions (crystalloid and hydroxyethyl starch; saline group) for 48 hours. The primary endpoint was the occurrence of hyperchloraemic metabolic acidosis within 48 hours.

resultsForty-two patients were included, of whom one patient in each group was excluded (one consent withdrawn and one use of forbidden therapy). Nineteen patients (95%) in the saline group and thirteen (65%) in the balanced group presented with hyperchloraemic acidosis within the first 48 hours (hazard ratio = 0.28, 95% confidence interval [CI] = 0.11 to 0.70; P = 0.006). In the saline group, pH (P = .004) and strong ion deficit (P = 0.047) were lower and chloraemia was higher (P = 0.002) than in the balanced group. Intracranial pressure was not different between the study groups (mean difference 4 mmHg [-1;8]; P = 0.088). Seven patients (35%) in the saline group and eight (40%) in the balanced group developed intracranial hypertension (P = 0.744). Three patients (14%) in the saline group and five (25%) in the balanced group died (P = 0.387).

conclusionsThis study provides evidence that balanced solutions reduce the incidence of hyperchloraemic acidosis in brain-injured patients compared to saline solutions. Even if the study was not powered sufficiently for this endpoint, intracranial pressure did not appear different between groups.

trial registrationEudraCT 2008-004153-15 and NCT00847977.

Indexed as

AcidosisAdultAgedBrain InjuriesCrystalloid SolutionsDouble-Blind MethodFemaleFluid TherapyFranceHumansHydroxyethyl Starch DerivativesIsotonic SolutionsMaleMiddle AgedPilot ProjectsSodium ChlorideCrystalloid SolutionsHydroxyethyl Starch DerivativesIsotonic SolutionsSodium Chloride

Identifiers

PMID23601796
PMCPMC4057192
OpenAlexW2143308705

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.