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Abstract：
OBJECTIVE: The routine use of stress ulcer prophylaxis (SUP) in infants with congenital heart disease (CHD) in the cardiac ICU (CICU) is controversial. We aimed to conduct a pilot study to explore the feasibility of performing a subsequent larger trial to assess the safety and efficacy of withholding SUP in this population (NCT03667703).
METHODS: Single-center, prospective, double-blinded, parallel group (SUP vs. placebo), pilot randomized controlled pilot trial (RCT) in infants with CHD admitted to the CICU and anticipated to require respiratory support for greater than 24 hours.
METHODS: Patients were randomized 1:1 (stratified by age and admission type) to receive a histamine-2 receptor antagonist or placebo until respiratory support was discontinued, up to 14 days, or transfer from the CICU, if earlier.
RESULTS: Feasibility was defined a priori by thresholds of screening rate, consent rate, timely drug allocation, and protocol adherence. The safety outcome was the rate of clinically significant upper gastrointestinal (UGI) bleeding. We screened 1,426 patients from February 2019 to March 2022; of 132 eligible patients, we gained informed consent in 70 (53%). Two patients did not require CICU admission after obtaining consent, and the remaining 68 patients were randomized to SUP (n = 34) or placebo (n = 34). Ten patients were withdrawn early, because of a change in eligibility (n = 3) or open-label SUP use (n = 7, 10%). Study procedures were completed in 58 patients (89% protocol adherence). All feasibility criteria were met. There were no clinically significant episodes of UGI bleeding during the pilot RCT. The percentage of patients with other nonserious adverse events did not differ between groups.
CONCLUSIONS: Withholding of SUP in infants with CHD admitted to the CICU was feasible. A larger multicenter RCT designed to confirm the safety of this intervention and its impact on incidence of UGI bleeding, gastrointestinal microbiome, and other clinical outcomes is warranted.
METHODS: Single-center, prospective, double-blinded, parallel group (SUP vs. placebo), pilot randomized controlled pilot trial (RCT) in infants with CHD admitted to the CICU and anticipated to require respiratory support for greater than 24 hours.
METHODS: Patients were randomized 1:1 (stratified by age and admission type) to receive a histamine-2 receptor antagonist or placebo until respiratory support was discontinued, up to 14 days, or transfer from the CICU, if earlier.
RESULTS: Feasibility was defined a priori by thresholds of screening rate, consent rate, timely drug allocation, and protocol adherence. The safety outcome was the rate of clinically significant upper gastrointestinal (UGI) bleeding. We screened 1,426 patients from February 2019 to March 2022; of 132 eligible patients, we gained informed consent in 70 (53%). Two patients did not require CICU admission after obtaining consent, and the remaining 68 patients were randomized to SUP (n = 34) or placebo (n = 34). Ten patients were withdrawn early, because of a change in eligibility (n = 3) or open-label SUP use (n = 7, 10%). Study procedures were completed in 58 patients (89% protocol adherence). All feasibility criteria were met. There were no clinically significant episodes of UGI bleeding during the pilot RCT. The percentage of patients with other nonserious adverse events did not differ between groups.
CONCLUSIONS: Withholding of SUP in infants with CHD admitted to the CICU was feasible. A larger multicenter RCT designed to confirm the safety of this intervention and its impact on incidence of UGI bleeding, gastrointestinal microbiome, and other clinical outcomes is warranted.
摘要：
目的：心脏ICU（CICU）中先天性心脏病（CHD）婴儿的应激性溃疡预防（SUP）的常规使用存在争议。我们旨在进行一项初步研究，以探索进行后续更大试验以评估该人群中预扣SUP的安全性和有效性的可行性（NCT03667703）。
方法：单中心，prospective,双盲,平行组(SUPvs.安慰剂)，在接受CICU并预期需要呼吸支持超过24小时的CHD婴儿中进行的前瞻性随机对照试验（RCT）。
方法：患者以1:1（按年龄和入院类型分层）随机接受组胺-2受体拮抗剂或安慰剂，直至停止呼吸支持。长达14天,或从CICU转移，如果更早。
结果：可行性是由筛查率的阈值预先定义的，同意率,及时配药,和协议的遵守。安全性结果是临床上消化道（UGI）出血的发生率。我们从2019年2月至2022年3月筛查了1,426例患者；在132例符合条件的患者中，我们在70例(53%)中获得了知情同意.两名患者在获得同意后不需要接受CU，其余68例患者随机接受SUP(n=34)或安慰剂(n=34).10名患者提前退出,由于资格（n=3）或开放标签SUP使用（n=7，10％）的变化。58例患者完成了研究程序（89％的方案依从性）。符合所有可行性标准。在飞行员RCT期间，没有临床上明显的UGI出血发作。其他非严重不良事件患者的百分比在组间没有差异。
结论：在接受CICU的CHD患儿中保留SUP是可行的。更大的多中心RCT旨在确认这种干预的安全性及其对UGI出血发生率的影响，胃肠道微生物组，和其他临床结果是必要的。
方法：单中心，prospective,双盲,平行组(SUPvs.安慰剂)，在接受CICU并预期需要呼吸支持超过24小时的CHD婴儿中进行的前瞻性随机对照试验（RCT）。
方法：患者以1:1（按年龄和入院类型分层）随机接受组胺-2受体拮抗剂或安慰剂，直至停止呼吸支持。长达14天,或从CICU转移，如果更早。
结果：可行性是由筛查率的阈值预先定义的，同意率,及时配药,和协议的遵守。安全性结果是临床上消化道（UGI）出血的发生率。我们从2019年2月至2022年3月筛查了1,426例患者；在132例符合条件的患者中，我们在70例(53%)中获得了知情同意.两名患者在获得同意后不需要接受CU，其余68例患者随机接受SUP(n=34)或安慰剂(n=34).10名患者提前退出,由于资格（n=3）或开放标签SUP使用（n=7，10％）的变化。58例患者完成了研究程序（89％的方案依从性）。符合所有可行性标准。在飞行员RCT期间，没有临床上明显的UGI出血发作。其他非严重不良事件患者的百分比在组间没有差异。
结论：在接受CICU的CHD患儿中保留SUP是可行的。更大的多中心RCT旨在确认这种干预的安全性及其对UGI出血发生率的影响，胃肠道微生物组，和其他临床结果是必要的。
