Evidence map›Paper›PMID 33430927›Full record

ArticleTrials2021

Viral load-guided immunosuppression after lung transplantation (VIGILung)-study protocol for a randomized controlled trial.

Jens Gottlieb, Alexander Reuss, Konstantin Mayer, Karin Weide, Carmen Schade-Brittinger, Susanne Hoyer, Peter Jaksch

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04198506 (Viral Load Guided Immunosuppression After Lung Transplantation, an Open-label, Randomized, Controlled, Parallel-group, Multicenter Trial), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
3.6field-weighted citation impact, top 7% 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.

NCT04198506 nacompletednot on this map

Viral Load Guided Immunosuppression After Lung Transplantation, an Open-label, Randomized, Controlled, Parallel-group, Multicenter Trial

TypeinterventionalSponsorPhilipps University MarburgRan2020 to 2025Enrolled146ConditionsTransplantation LungArmsTailored tacrolimus dosing, Conventional tacrolimus dosing
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Guideline
  2. Review
  3. Article
  4. Post-lung transplant surveillance in 2026: current practice, variability, and the need for standardization.Transplant international : official journal of the European Society for Organ Transplantation · 2026
    Review
  5. Review
  6. Article
  7. Review
  8. Article
  9. Article
  10. Article
  11. Molecular monitoring of lung allograft health: is it ready for routine clinical use?European respiratory review : an official journal of the European Respiratory Society · 2023
    Review
  12. Review
  13. Article
  14. Review
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

7 authors at 4 institutions in 2 countries.

Jens GottliebDepartment of Respiratory Medicine OE6870, Hannover Medical School, 30625, Hannover, Germany. gottlieb.jens@mh-hannover.de.ORCID http://orcid.org/0000-0002-9540-9022
Alexander ReussCoordinating Centre for Clinical Trials Marburg (KKS Marburg), Philipps-University Marburg, Marburg, Germany.
Konstantin MayerUniversity of Giessen and Marburg Lung Center (UGMLC), University Hospital Giessen, Justus Liebig University of Giessen, Giessen, Germany.
Karin WeideCoordinating Centre for Clinical Trials Marburg (KKS Marburg), Philipps-University Marburg, Marburg, Germany.
Carmen Schade-BrittingerCoordinating Centre for Clinical Trials Marburg (KKS Marburg), Philipps-University Marburg, Marburg, Germany.
Susanne HoyerDepartment of Respiratory Medicine OE6870, Hannover Medical School, 30625, Hannover, Germany.
Peter JakschDivision of Thoracic Surgery, Medical University of Vienna, Vienna, Austria.
Philipps University of Marburg · DEMedizinische Hochschule Hannover · DEJustus-Liebig-Universität Gießen · DEMedical University of Vienna · AT

Funding

Deutsche Forschungsgemeinschaft 329015138
6 · The paper itself

Abstract

backgroundImmunosuppression including high-dose calcineurin inhibitors (CNI) is essential after lung transplantation. Dosing is usually guided by therapeutic drug monitoring adjusted to target trough levels of CNIs to keep the balance between over-dose causing severe toxicity and increased risk of infections or under-dose with a risk of graft injury. Adaptation of CNI-based immunosuppression by monitoring of torque teno virus (TTV), a latent nonpathogenic DNA virus, measured in the whole blood in addition to conventional therapeutic drug monitoring may reduce the toxicity of immunosuppression with similar efficacy. METHODS/

designAn open-label, randomized, controlled, parallel-group, multicenter trial in lung transplant recipients will be conducted to investigate the safety and efficacy of immunosuppression guided by TTV monitoring as an add-on to conventional therapeutic drug monitoring. Adult lung transplant recipients 21 to 42 days after transplantation are eligible to participate. Patients (N = 144) will be randomized 1:1 to the experimental intervention (arm 1: immunosuppression guided by TTV monitoring in addition to conventional therapeutic drug monitoring of tacrolimus trough levels) and control intervention (arm 2: conventional therapeutic drug monitoring). Outcomes will be assessed 12 months after randomization with the change in glomerular filtration rate as the primary endpoint. Secondary endpoints will be additional measurements of renal function, allograft function, incidence of acute rejections, incidence of chronic lung allograft dysfunction, graft loss, and infections. DISCUSSION: The results of this randomized controlled trial may reduce the toxicity of immunosuppression after lung transplantation while maintaining the efficacy of immunosuppression. Study results are transferable to all other solid organ transplantations.

trial registrationClinicalTrials.gov NCT04198506 . Registered on 12 December 2019.

Indexed as

Immunosuppressive AgentsLung TransplantationAdultGraft RejectionHumansImmunosuppression TherapyMulticenter Studies as TopicRandomized Controlled Trials as TopicViral LoadImmunosuppressive AgentsGraft rejectionImmunosuppressionKidney failureLung transplantationRandomized controlled trialTorque teno virus

Identifiers

PMID33430927
PMCPMC7798016
OpenAlexW3118608551

What OpenQuestion holds

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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.