Evidence map›Paper›PMID 27779776›Full record

ArticleBritish journal of clinical pharmacology2017

A Phase I study to determine the pharmacokinetic profile, safety and tolerability of sildenafil (Revatio

Arne Ring, Tom Morris, Marcin Wozniak, Nikol Sullo, William Dott, Veerle Verheyden, Tracy Kumar, Nigel Brunskill, Rakesh Vaja, Gavin J Murphy

Open access · bronzeAbstract readClinical Trial, Phase IComparative Study
In one paragraph

Article in British journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 20% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Statistical reporting of clinical pharmacology research.British journal of clinical pharmacology · 2017
    Article
  5. Article
  6. 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

10 authors at 4 institutions in 3 countries.

Arne RingUniversity of the Free State, Bloemfontein, South Africa.ORCID 0000-0002-4324-5820
Tom MorrisLeicester Clinical Trials Unit, Leicester General Hospital, Leicester, UK.
Marcin WozniakUniversity of Leicester, Cardiovascular Sciences and NIHR Cardiovascular Biomedical Research Unit, Glenfield Hospital, Leicester, UK.
Nikol SulloUniversity of Leicester, Cardiovascular Sciences and NIHR Cardiovascular Biomedical Research Unit, Glenfield Hospital, Leicester, UK.
William DottUniversity of Leicester, Cardiovascular Sciences and NIHR Cardiovascular Biomedical Research Unit, Glenfield Hospital, Leicester, UK.
Veerle VerheydenUniversity of Leicester, Cardiovascular Sciences and NIHR Cardiovascular Biomedical Research Unit, Glenfield Hospital, Leicester, UK.
Tracy KumarUniversity of Leicester, Cardiovascular Sciences and NIHR Cardiovascular Biomedical Research Unit, Glenfield Hospital, Leicester, UK.
Nigel BrunskillUniversity Hospitals Leicester NHS Trust, Leicester, UK.
Rakesh VajaUniversity Hospitals Leicester NHS Trust, Leicester, UK.
Gavin J MurphyUniversity of Leicester, Cardiovascular Sciences and NIHR Cardiovascular Biomedical Research Unit, Glenfield Hospital, Leicester, UK.
University of Leicester · GBUniversity Hospitals of Leicester NHS Trust · GBLeicester General Hospital · GBUniversity of the Free State · ZA

Funding

British Heart Foundation CH/12/1/29419British Heart Foundation RG/13/6/29947
6 · The paper itself

Abstract

aimsAcute kidney injury (AKI) is a common and severe complication of cardiac surgery. There is no effective prevention or treatment. Sildenafil citrate (Revatio

methodsWe conducted an open label, dose escalation study with six patients per dose level. The six doses were 2.5 mg, 5 mg or 10 mg as a bolus, either alone or followed by an additional 2 h infusion of 2.5 mg sildenafil.

resultsThirty-six patients entered the trial, of which 33 completed it. The mean age was 69.9 years. One patient died during surgery, two others were removed from the trial before dosing (all at dose level 5 mg + 2.5 mg). The pharmacokinetic profile of sildenafil was similar to previously published studies. For a dose of 10 mg administered as a bolus followed by 2.5 mg administered over 2 h the results were AUC

conclusionsPharmacokinetics of sildenafil during cardiopulmonary bypass were comparable to those of other patient groups. The drug was well tolerated at therapeutic plasma levels. These results support the further evaluation of sildenafil for the prevention of AKI in cardiac surgery.

Indexed as

Acute Kidney InjuryAdministration, IntravenousAgedCardiac Surgical ProceduresCardiopulmonary BypassDose-Response Relationship, DrugFemaleHumansMaleMiddle AgedNitric OxidePhosphodiesterase 5 InhibitorsPostoperative ComplicationsSildenafil CitrateNitric OxidePhosphodiesterase 5 InhibitorsSildenafil Citratecardiac surgeryclinical pharmacologydose proportionalitynitrite oxidepharmacokineticssildenafil

Identifiers

PMID27779776
PMCPMC5346869
OpenAlexW2540737237

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.