Evidence map›Paper›PMID 30587165›Full record

ArticleBMC surgery2018

The addition of simvastatin administration to cold storage solution of explanted whole liver grafts for facing ischemia/reperfusion injury in an area with a low rate of deceased donation: a monocentric randomized controlled double-blinded phase 2 study.

Duilio Pagano, Elisabetta Oliva, Simone Khouzam, Fabio Tuzzolino, Davide Cintorino, Sergio Li Petri, Fabrizio di Francesco, Calogero Ricotta, Pasquale Bonsignore, Alessandro Tropea and 4 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC surgery, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.2field-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

4 citing papers in PubMed, 9 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. 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

14 authors at 4 institutions in 2 countries.

Duilio PaganoDepartment for the Treatment and Study of Abdominal Diseases and Abdominal Transplantation, IRCCS-ISMETT (Istituto di Ricovero e Cura a Carattere Scientifico - Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione), UPMC (University of Pittsburgh Medical Center) Italy, Via E. Tricomi 5, 90127, Palermo, Italy.
Elisabetta OlivaFondazione Ri.MED, Palermo, Italy.
Simone KhouzamSidney Kimmel Medical College - Thomas Jefferson University, Philadelphia, PA, USA.
Fabio TuzzolinoResearch Office, IRCCS-ISMETT, UPMC Italy, Palermo, Italy.
Davide CintorinoDepartment for the Treatment and Study of Abdominal Diseases and Abdominal Transplantation, IRCCS-ISMETT (Istituto di Ricovero e Cura a Carattere Scientifico - Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione), UPMC (University of Pittsburgh Medical Center) Italy, Via E. Tricomi 5, 90127, Palermo, Italy.
Sergio Li PetriDepartment for the Treatment and Study of Abdominal Diseases and Abdominal Transplantation, IRCCS-ISMETT (Istituto di Ricovero e Cura a Carattere Scientifico - Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione), UPMC (University of Pittsburgh Medical Center) Italy, Via E. Tricomi 5, 90127, Palermo, Italy.
Fabrizio di FrancescoDepartment for the Treatment and Study of Abdominal Diseases and Abdominal Transplantation, IRCCS-ISMETT (Istituto di Ricovero e Cura a Carattere Scientifico - Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione), UPMC (University of Pittsburgh Medical Center) Italy, Via E. Tricomi 5, 90127, Palermo, Italy.
Calogero RicottaDepartment for the Treatment and Study of Abdominal Diseases and Abdominal Transplantation, IRCCS-ISMETT (Istituto di Ricovero e Cura a Carattere Scientifico - Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione), UPMC (University of Pittsburgh Medical Center) Italy, Via E. Tricomi 5, 90127, Palermo, Italy.
Pasquale BonsignoreDepartment for the Treatment and Study of Abdominal Diseases and Abdominal Transplantation, IRCCS-ISMETT (Istituto di Ricovero e Cura a Carattere Scientifico - Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione), UPMC (University of Pittsburgh Medical Center) Italy, Via E. Tricomi 5, 90127, Palermo, Italy.
Alessandro TropeaDepartment for the Treatment and Study of Abdominal Diseases and Abdominal Transplantation, IRCCS-ISMETT (Istituto di Ricovero e Cura a Carattere Scientifico - Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione), UPMC (University of Pittsburgh Medical Center) Italy, Via E. Tricomi 5, 90127, Palermo, Italy.
Sergio CalamiaDepartment for the Treatment and Study of Abdominal Diseases and Abdominal Transplantation, IRCCS-ISMETT (Istituto di Ricovero e Cura a Carattere Scientifico - Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione), UPMC (University of Pittsburgh Medical Center) Italy, Via E. Tricomi 5, 90127, Palermo, Italy.
Federico CostanzoDepartment for the Treatment and Study of Abdominal Diseases and Abdominal Transplantation, IRCCS-ISMETT (Istituto di Ricovero e Cura a Carattere Scientifico - Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione), UPMC (University of Pittsburgh Medical Center) Italy, Via E. Tricomi 5, 90127, Palermo, Italy.
Angelo LucaDepartment of Diagnostic and Therapeutic Services, IRCCS-ISMETT, UPMC Italy, Palermo, Italy.
Salvatore GruttadauriaDepartment for the Treatment and Study of Abdominal Diseases and Abdominal Transplantation, IRCCS-ISMETT (Istituto di Ricovero e Cura a Carattere Scientifico - Istituto Mediterraneo per i Trapianti e Terapie ad alta specializzazione), UPMC (University of Pittsburgh Medical Center) Italy, Via E. Tricomi 5, 90127, Palermo, Italy. sgruttadauria@ismett.edu.ORCID http://orcid.org/0000-0002-9684-8035
Istituti di Ricovero e Cura a Carattere Scientifico · ITIstituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione · ITRi.MED · ITThomas Jefferson University · US

Funding

Ministero della Salute GR-2013-02357764
6 · The paper itself

Abstract

backgroundLiver transplantation is the best treatment for end-stage liver disease. The interruption of the blood supply to the donor liver during cold storage damages the liver, affecting how well the liver will function after transplant. The drug Simvastatin may help to protect donor livers against this damage and improve outcomes for transplant recipients. The aim of this study is to evaluate the benefits of treating the donor liver with Simvastatin compared with the standard transplant procedure. PATIENT AND

methodsWe propose a prospective, double-blinded, randomized phase 2 study of 2 parallel groups of eligible adult patients. We will compare 3-month, 6-month, and 12-month graft survival after LT, in order to identify a significant relation between the two homogenous groups of LT patients. The two groups only differ by the Simvastatin or placebo administration regimen while following the same procedure, with identical surgical instruments, and medical and nursing skilled staff. To reach these goals, we determined that we needed to recruit 106 patients. This sample size achieves 90% power to detect a difference of 14.6% between the two groups survival using a one-sided binomial test. DISCUSSION: This trial is designed to confirm the effectiveness of Simvastatin to protect healthy and steatotic livers undergoing cold storage and warm reperfusion before transplantation and to evaluate if the addition of Simvastatin translates into improved graft outcomes.

trial registrationISRCTN27083228 .

Indexed as

Liver TransplantationOrgan PreservationSimvastatinClinical Trials, Phase II as TopicDouble-Blind MethodFatty LiverHumansLiverOrgan Preservation SolutionsProspective StudiesProtective AgentsRandomized Controlled Trials as TopicReperfusion InjuryOrgan Preservation SolutionsProtective AgentsSimvastatinDonor after brain deathIschemia/reperfusion injuryLiver transplantationSimvastatin

Identifiers

PMID30587165
PMCPMC6307270
OpenAlexW2906970670

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.