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ArticleActa anaesthesiologica Scandinavica2020

Noninterventional follow-up vs fluid bolus in RESPONSE to oliguria-The RESPONSE trial protocol and statistical analysis plan.

Nina Inkinen, Tuomas Selander, Ville Pettilä, Miia Valkonen, Minna Bäcklund, Johanna Wennervirta, Anni Pulkkinen, Johanna Hästbacka, Suvi T Vaara

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Acta anaesthesiologica Scandinavica, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02860572 (Non-interventional Follow-up Versus Fluid Bolus in RESPONSE to Oliguria in the Optimization Phase of Fluid Therapy in the Critically Ill), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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.

NCT02860572 nacompletednot on this map

Non-interventional Follow-up Versus Fluid Bolus in RESPONSE to Oliguria in the Optimization Phase of Fluid Therapy in the Critically Ill (the RESPONSE Trial)

TypeinterventionalSponsorHelsinki University Central HospitalRan2017 to 2020Enrolled130ConditionsCritically Ill, Acute Kidney Injury, Sepsis, OliguriaArmsfollow-up without intervention, fluid bolus
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Trial
  3. 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

9 authors.

Nina InkinenDepartment of Anesthesia and Intensive Care, Central Finland Central Hospital, Central Finland Health Care District, Jyväskylä, Finland.ORCID 0000-0002-2551-9322
Tuomas SelanderScience Service Center, Kuopio University Hospital, Kuopio, Finland.
Ville PettiläDivision of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.ORCID 0000-0002-3921-4423
Miia ValkonenDivision of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
Minna BäcklundDivision of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
Johanna WennervirtaDivision of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
Anni PulkkinenDepartment of Anesthesia and Intensive Care, Central Finland Central Hospital, Central Finland Health Care District, Jyväskylä, Finland.
Johanna HästbackaDivision of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.ORCID 0000-0002-3613-7231
Suvi T VaaraDivision of Intensive Care Medicine, Department of Anesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOliguria is a frequent trigger for administering a fluid bolus, but the effect of fluid bolus in improving urine output is inadequately demonstrated. Here, we summarize the protocol and detailed statistical analysis plan of the randomized, controlled RESPONSE trial comparing follow-up as the experimental group and a 500 mL crystalloid fluid bolus as the control group for oliguria in critically ill oliguric patients.

methodsOur trial is an investigator-initiated, randomized, controlled, pilot trial conducted in three ICUs in two centers. We aim to randomize 1:1 altogether 130 hemodynamically stable oliguric patients either to a 2-hour follow-up without interventions or to receive a crystalloid bolus of 500 mL over 30 minutes. The primary outcome is the change in individual urine output during the 2-hour period compared to 2 hours preceding randomization. Doubling of the urine output is considered clinically significant. Additionally, we record the duration of oliguria, physiological and biochemical variables, adverse events, and the incidences of acute kidney injury and renal replacement therapy.

conclusionsOliguria is a frequent trigger for potentially harmful fluid loading. Therefore, the RESPONSE trial will give information of the potential effect of fluid bolus on oliguria in critically ill patients.

trial registrationclinical.trials.gov, NCT02860572.

Indexed as

Crystalloid SolutionsFluid TherapyOliguriaResearch DesignAdultCritical CareCritical IllnessFinlandFollow-Up StudiesHumansMulticenter Studies as TopicPilot ProjectsRandomized Controlled Trials as TopicTime FactorsTreatment OutcomeYoung AdultCrystalloid Solutionsacute kidney injurycritically illfluid bolusoliguria

Identifiers

PMID32270496
PMCPMC7496618

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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.