Evidence map›Paper›PMID 34851445›Full record

Trial reportPediatric cardiology2022

Indonesian Study: Triiodothyronine for Infants Less than 5 Months Undergoing Cardiopulmonary Bypass.

Eva Miranda Marwali, Albert Lopolisa, Alvin A Sani, Muhammad Rayhan, Poppy S Roebiono, Dicky Fakhri, Nikolaus A Haas, April Slee, Michael A Portman

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Pediatric cardiology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02222532 (Tetronine), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
0.4field-weighted citation impact, top 34% 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.

NCT02222532 phase3completednot on this map

Tetronine (Sodium Liothyronine) for Infants & Children Undergoing Cardiopulmonary Bypass in a Middle Income Nation (OTICC Study)

TypeinterventionalSponsorNational Cardiovascular Center Harapan Kita Hospital IndonesiaRan2013 to 2015Enrolled224ConditionsPostoperative, Dysfunction Following Cardiac SurgeryArmsTetronine, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 3 citations in OpenAlex.

  1. Pooled it
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 at 3 institutions in 2 countries.

Eva Miranda MarwaliPediatric Cardiac Intensive Care Unit, National Cardiovascular Center Harapan Kita, Jakarta, Indonesia. eva.marwali@pjnhk.go.id.ORCID http://orcid.org/0000-0002-0135-536X
Albert LopolisaPediatric Cardiac Intensive Care Unit, National Cardiovascular Center Harapan Kita, Jakarta, Indonesia.
Alvin A SaniPediatric Cardiac Intensive Care Unit, National Cardiovascular Center Harapan Kita, Jakarta, Indonesia.
Muhammad RayhanPediatric Cardiac Intensive Care Unit, National Cardiovascular Center Harapan Kita, Jakarta, Indonesia.
Poppy S RoebionoDepartment of Cardiology and Vascular Medicine, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.
Dicky FakhriPediatric Cardiac Surgery Unit, National Cardiovascular Center Harapan Kita, Department of Cardiothoracic Vascular Surgery, Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia.
Nikolaus A HaasDepartment of Pediatric Cardiology and Pediatric Intensive Care, Medical Hospital of the University of Munich, Munich, Germany.
April SleeAxio Research, Seattle Children's Hospital and Research Institute, Seattle, USA.
Michael A PortmanSeattle Children's Hospital, University of Washington, Seattle, WA, USA.
National Brain Centre · IDUniversity of Indonesia · IDSeattle Children's Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study evaluates the efficacy and safety of oral triiodothyronine on time to extubation for infants less than 5 months undergoing heart surgery in Indonesia, and primarily relates to patients in emerging programs with high malnutrition and mortality. In this randomized, double-blind, placebo-controlled trial, oral triiodothyronine (T3, Tetronine®) 1 μg/kg-body weight/dose or placebo (saccharum lactis) was administered via nasogastric tube every 6 h for 60 h to treatment group. A total of 120 patients were randomized into T3 (61 patients) and placebo (59 patients) groups. The majority of the patients had moderate to severe malnutrition (55.83%) with a high post-operative mortality rate of 23.3%. The T3 group showed significantly higher serum FT3 levels from 1 until 48 h post cross-clamp removal (p < 0.0001), lower incidence of low cardiac output syndrome at both 6 h (28 [45.9%] vs. 39 [66.1%] patients, p = 0.03, OR 2.3, 95% CI: 1.10-4.81) and 12 h after cross-clamp removal (25 [41.7%] vs. 36 [63.2%], p = 0.02, OR 2.40, 95% CI: 1.14-5.05). Although not statistically significant, the treatment group had shorter median (IQR) intubation time (2.59 [1.25-5.24] vs. 3.77 [1.28-6.64] days, p = 0.16, HR 1.36, 95% CI: 0.88-2.09)] and lower mortality (10 [16.4%] vs. 18 [30.5%], p = 0.07]. Patients with Aristotle score < 10.0 (low risk) receiving T3 had faster extubation than placebo patients (p = 0.021, HR of 1.90, 95% CI: 1.10-3.28) and were significantly less likely to require CPR or experience infection (p = 0.027, OR 8.56, 95% CI:0.99-73.9 and p = 0.022, OR 4.09 95% CI: 1.16-14.4, respectively). Oral T3 supplementation reduced overall incidence of low cardiac output syndrome and significantly reduced the time to extubation in low-risk patients. Therefore, prophylactic oral T3 administration may be beneficial in these patients.Trial Registration: ClinicalTrials.gov NCT02222532.

Indexed as

MalnutritionTriiodothyronineCardiac Output, LowCardiopulmonary BypassDouble-Blind MethodHumansIndonesiaInfantTriiodothyronineCongenital open cardiac surgeryLow cardiac outputTime-to-extubationTriiodothyronine

Identifiers

PMID34851445
OpenAlexW3217541841

What OpenQuestion holds

Textmetadata
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.