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Abstract：
OBJECTIVE: To test the effectiveness of nurse-led dietary diabetes insipidus (DI) bundle on the severity of postoperative fluid imbalance in pituitary region tumours.
METHODS: Blinded randomized controlled trial.
METHODS: Patients aged 18-65 operated for sellar-suprasellar tumours in an Indian tertiary care centre were enrolled through total enumeration sampling and underwent randomization with allocation concealment during Sep 2018-Feb 2019. Pre-operative DI, postoperative ventilation, renal failure or decompensated diabetes mellitus were excluded. Patients in the intervention group received a nurse-led DI bundle (validated by three Delphi rounds) with four dietary components: intake of only water during thirst and avoidance of the following-added salt, high-protein foods and caffeinated drinks. Treating clinicians and the investigator assessing outcome were blinded about enrolment. Urine output, serum sodium, vasopressin requirement and hospital stay were assessed as primary outcomes. The outcome measures were monitored daily till the 6th postoperative day. Analyses were performed on \'intention-to-treat\' basis, irrespective of compliance. Independent t-test and Chi-square test were used.
RESULTS: Of the initial 63 patients, 50 fulfilling criteria were randomized to two groups and assessed over six days yielding 150 patient-days per group. There were no significant baseline differences between groups. The mean daily urine output was significantly lower in the DI bundle group than in control, both overall and among endonasal operated pituitary adenomas [3000.09(462.7) vs. 4095.71(896.4)ml & 2987.14(419.5) vs. 4064.73(1051)ml], with the greatest difference on the second postoperative day. Though hypernatraemia in controls became most prominent during days 2-3 and resolved in a week, it was significantly lower in the intervention group (12.7% vs. 30.7% overall, 11.4% vs. 29.4% endonasal adenomas). The need for vasopressin analogues and hospital stay were also significantly lower with DI bundle (p < 0.001).
CONCLUSIONS: This is probably the first ever report of dietary DI bundle among operated pituitary patients, which seem to flatten the DI trend with significant benefits in polyuria, hypernatraemia, vasopressin requirement and hospital stay.
BACKGROUND: CTRI/2018/07/015127 of ICMR.
CONCLUSIONS: The nurse-led dietary DI bundle has effectively reduced the severity of DI among operated pituitary patients with significant benefits in polyuria, hypernatraemia, vasopressin requirement and hospital stay. Its implementation is simple and easy to carry out, especially in resource-constrained institutions, where continuous monitoring and repeated serum sodium estimation are difficult.
METHODS: Blinded randomized controlled trial.
METHODS: Patients aged 18-65 operated for sellar-suprasellar tumours in an Indian tertiary care centre were enrolled through total enumeration sampling and underwent randomization with allocation concealment during Sep 2018-Feb 2019. Pre-operative DI, postoperative ventilation, renal failure or decompensated diabetes mellitus were excluded. Patients in the intervention group received a nurse-led DI bundle (validated by three Delphi rounds) with four dietary components: intake of only water during thirst and avoidance of the following-added salt, high-protein foods and caffeinated drinks. Treating clinicians and the investigator assessing outcome were blinded about enrolment. Urine output, serum sodium, vasopressin requirement and hospital stay were assessed as primary outcomes. The outcome measures were monitored daily till the 6th postoperative day. Analyses were performed on \'intention-to-treat\' basis, irrespective of compliance. Independent t-test and Chi-square test were used.
RESULTS: Of the initial 63 patients, 50 fulfilling criteria were randomized to two groups and assessed over six days yielding 150 patient-days per group. There were no significant baseline differences between groups. The mean daily urine output was significantly lower in the DI bundle group than in control, both overall and among endonasal operated pituitary adenomas [3000.09(462.7) vs. 4095.71(896.4)ml & 2987.14(419.5) vs. 4064.73(1051)ml], with the greatest difference on the second postoperative day. Though hypernatraemia in controls became most prominent during days 2-3 and resolved in a week, it was significantly lower in the intervention group (12.7% vs. 30.7% overall, 11.4% vs. 29.4% endonasal adenomas). The need for vasopressin analogues and hospital stay were also significantly lower with DI bundle (p < 0.001).
CONCLUSIONS: This is probably the first ever report of dietary DI bundle among operated pituitary patients, which seem to flatten the DI trend with significant benefits in polyuria, hypernatraemia, vasopressin requirement and hospital stay.
BACKGROUND: CTRI/2018/07/015127 of ICMR.
CONCLUSIONS: The nurse-led dietary DI bundle has effectively reduced the severity of DI among operated pituitary patients with significant benefits in polyuria, hypernatraemia, vasopressin requirement and hospital stay. Its implementation is simple and easy to carry out, especially in resource-constrained institutions, where continuous monitoring and repeated serum sodium estimation are difficult.
摘要：
目的：测试护士主导的饮食尿崩症（DI）束对垂体区肿瘤术后液体失衡严重程度的有效性。
方法：盲法随机对照试验。
方法：在印度三级护理中心接受鞍上肿瘤手术的18-65岁患者通过总计数抽样进行招募，并在2018年9月至2019年2月期间进行了随机分配隐藏。术前DI,术后通气,肾功能衰竭或失代偿性糖尿病被排除.干预组的患者接受了由护士主导的DI捆绑（通过三个德尔菲回合验证），其中包含四种饮食成分：口渴时仅摄入水，并避免使用以下添加的盐，高蛋白食物和含咖啡因的饮料。治疗的临床医生和研究者对结果评估的结果是盲目的。尿液输出，血清钠，作为主要结局,我们评估了加压素需求和住院时间.每天监测结局指标，直至术后第6天。分析是在“意向治疗”的基础上进行的，不管遵守。采用独立t检验和卡方检验。
结果：在最初的63名患者中，将50项符合标准随机分为两组，并在六天内进行评估，每组150名患者。组间基线无显著差异。DI束组的平均每日尿量显着低于对照组，整体和鼻内手术垂体腺瘤[3000.09（462.7）vs.4095.71（896.4）ml和2987.14（419.5）vs.4064.73(1051)ml],在术后第二天差异最大。尽管对照组的高钠血症在第2-3天最为突出，并在一周内消退，干预组明显较低(12.7%vs.整体30.7%,11.4%与29.4%鼻内腺瘤)。使用DI束对加压素类似物的需求和住院时间也显著降低(p<0.001)。
结论：这可能是在垂体手术患者中关于饮食DI束的第一份报告，这似乎使DI趋势变得平坦，在多尿中具有显著的益处，高钠血症,加压素需求和住院时间。
背景：ICMR的CTRI/2018/07/015127。
结论：护士主导的饮食DI束有效降低了垂体手术患者DI的严重程度，对多尿有显著益处，高钠血症,加压素需求和住院时间。其实现简单易行,特别是在资源有限的机构中，连续监测和重复血清钠估计是困难的。
方法：盲法随机对照试验。
方法：在印度三级护理中心接受鞍上肿瘤手术的18-65岁患者通过总计数抽样进行招募，并在2018年9月至2019年2月期间进行了随机分配隐藏。术前DI,术后通气,肾功能衰竭或失代偿性糖尿病被排除.干预组的患者接受了由护士主导的DI捆绑（通过三个德尔菲回合验证），其中包含四种饮食成分：口渴时仅摄入水，并避免使用以下添加的盐，高蛋白食物和含咖啡因的饮料。治疗的临床医生和研究者对结果评估的结果是盲目的。尿液输出，血清钠，作为主要结局,我们评估了加压素需求和住院时间.每天监测结局指标，直至术后第6天。分析是在“意向治疗”的基础上进行的，不管遵守。采用独立t检验和卡方检验。
结果：在最初的63名患者中，将50项符合标准随机分为两组，并在六天内进行评估，每组150名患者。组间基线无显著差异。DI束组的平均每日尿量显着低于对照组，整体和鼻内手术垂体腺瘤[3000.09（462.7）vs.4095.71（896.4）ml和2987.14（419.5）vs.4064.73(1051)ml],在术后第二天差异最大。尽管对照组的高钠血症在第2-3天最为突出，并在一周内消退，干预组明显较低(12.7%vs.整体30.7%,11.4%与29.4%鼻内腺瘤)。使用DI束对加压素类似物的需求和住院时间也显著降低(p<0.001)。
结论：这可能是在垂体手术患者中关于饮食DI束的第一份报告，这似乎使DI趋势变得平坦，在多尿中具有显著的益处，高钠血症,加压素需求和住院时间。
背景：ICMR的CTRI/2018/07/015127。
结论：护士主导的饮食DI束有效降低了垂体手术患者DI的严重程度，对多尿有显著益处，高钠血症,加压素需求和住院时间。其实现简单易行,特别是在资源有限的机构中，连续监测和重复血清钠估计是困难的。
