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Correlation of measured and calculated serum osmolality during mannitol or hypertonic saline infusion in patients after craniotomy: a study protocol and statistical analysis plan for a randomised controlled trial.

ABSTRACT: Brain oedema is a major complication after craniotomy. Hyperosmolar agents have been used as the medical treatment for this condition. Measurement and estimation of serum osmolality during hyperosmolar agent infusion is of clinical importance to evaluate clinical efficacy, adjust dosage and avoid side effects. However, several studies have shown that calculated serum osmolality may lead to a systematic bias compared with direct measurement. In the present study, mannitol or hypertonic saline (HS) will be used in patients after elective craniotomy. We aim to determine the accuracy of serum osmolality estimation during the application of hyperosmolar agent.The study is a prospective, randomised, double-blinded, controlled, parallel-group design. Adult patients requiring the use of hyperosmolar agents for the prevention or treatment of postoperative brain oedema are enrolled and assigned randomly to one of the two treatment study groups, labelled as 'M group' and 'HS group'. Patients in the M and HS groups receive intravenous infusion of 125 mL of either 20% mannitol or 3.1% sodium chloride solution, respectively. Data will be collected immediately before the infusion of study agents, 15, 30, 60, 120, 240 and 360 min after the start of infusion of experimental agents, which includes serum osmolality, concentration of serum sodium, potassium, urea and glucose. Serum osmolality will be measured by means of freezing point depression. Estimated serum osmolality will also be calculated by using four formulas published previously. Osmole gap is calculated as the difference between the measured and the estimated values. The primary endpoint is the correlation of measured and estimated serum osmolality during hyperosmolar agent infusion.The study was approved by the International Review Board (IRB) of Beijing Tiantan Hospital, Capital Medical University. Study findings will be disseminated through peer-reviewed publications and conference presentations.ClinicalTrials.gov identifier: NCT02037815.

SUBMITTER: Li Q

PROVIDER: S-EPMC4010815 | biostudies-literature | 2014 Apr

REPOSITORIES: biostudies-literature

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Correlation of measured and calculated serum osmolality during mannitol or hypertonic saline infusion in patients after craniotomy: a study protocol and statistical analysis plan for a randomised controlled trial.

Li Qian Q Xu Ming M Zhou Jian-Xin JX

BMJ open 20140423 4

<h4>Introduction</h4>Brain oedema is a major complication after craniotomy. Hyperosmolar agents have been used as the medical treatment for this condition. Measurement and estimation of serum osmolality during hyperosmolar agent infusion is of clinical importance to evaluate clinical efficacy, adjust dosage and avoid side effects. However, several studies have shown that calculated serum osmolality may lead to a systematic bias compared with direct measurement. In the present study, mannitol or ...[more]

PMID: 24760352

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Project description:Mannitol and hypertonic saline are used to ameliorate brain edema and intracranial hypertension during and after craniotomy. We hypothesized that the agreement of measured and calculated serum osmolality during the infusion of hypertonic saline would be better than mannitol. The objective was to determine the accuracy of serum osmolality estimation by different formulas during the administration of hyperosmolar agent.A prospective, randomized, double-blinded, controlled trial was conducted in a 30-bed neurosurgical intensive care unit at a university hospital. Thirty-five adult patients requiring the use of hyperosmolar agents for prevention or treatment of brain edema after elective craniotomy were enrolled, and randomly assigned 1:1 to receive 125 mL of either 20 % mannitol (mannitol group) or 3.1 % sodium chloride solution (hypertonic saline group) in 15 min. Serum osmolality, serum sodium and potassium concentration, blood urea nitrogen and blood glucose concentration were measured during the study period. The primary outcome was the agreement of measured and estimated serum osmolality during the infusion of the two experimental agents. We used Bland and Altman's limits of agreement analysis to clarify the accuracy of estimated serum osmolality. Bias and upper and lower limits of agreement of bias were calculated.For each formula, the bias was statistically lower in hypertonic saline group than mannitol group (p < 0.001). Within group comparison showed that the lowest bias (6.0 [limits of agreement: -18.2 to 30.2] and 0.8 [-12.9 to 14.5] mOsml/kg in mannitol group and hypertonic saline group, respectively) was derived from the formula '2 × ([serum sodium]?+?[serum potassium])?+?[blood urea nitrogen]?+?[blood glucose]'.Compared to mannitol, a better agreement between measured and estimated serum osmolality was found during the infusion of hypertonic saline. This result indicates that, if hypertonic saline is chosen to prevent or treat brain edema, calculated serum osmolality can be used as a reliable surrogate for osmolality measurement.ClinicalTrials.gov identifier: NCT02037815.

Project description:Abstract Objectives Mild and moderate dehydration adversely affect mood and cognitive function. During dehydration, hypertonic hypovolemia activates both osmo- and baro-receptors but it is not known which physiological pathway is associated with degraded mood state. This study examined the acute effect of osmoreceptor stimulation on mood. Methods Sixty healthy adults (50% females, 30 ± 1 y; BMI: 26.9 ± 4.0 kg·m−2) were infused intravenously with 3.0% (HYPER) or 0.9% (ISO) NaCl for 2 h (0.1 ml·kg−1·min−1) using a counterbalanced, crossover design. Blood samples were collected every 30 minutes to measure plasma osmolality (POsm), copeptin (a surrogate marker of vasopressin), and renin-angiotensin-aldosterone system (RAAS) hormones. Mood was assessed with the short version of Profile of Mood State (POMS) questionnaire before and after the infusion. Results POsm and copeptin increased from 286 ± 3 mmol·kg−1 to 305 ± 4 mmol·kg−1 and from 4.5 ± 3.7 pmol·L−1 to 20.4 ± 12.8 pmol·L−1, respectively in HYPER (P < 0.05), and were unchanged in ISO (P > 0.05). No hormonal differences were observed between trials for RAAS hormones (P > 0.05). During HYPER copeptin, following the 2-h infusion, was greater in females than in males (female: 23.4 ± 13.9 pmol·L−1, male: 17.4 ± 10.9 pmol·L−1; P < 0.05). The POMS total mood disturbance (TMD) score increased from 10.5 ± 0.9 to 16.5 ± 1.6 in HYPER (P < 0.05), but not in ISO (P > 0.05). Among POMS subscales, depression-dejection and fatigue-inertia increased in HYPER compared to ISO (P < 0.05). When TMD responses in the HYPER trial were analyzed with sex as a between-subjects factor, the increase was significant in females (pre: 10.2 ± 1.0, post: 18.6 ± 2.3; P < 0.001) but not in males (pre: 10.8 ± 1.4, post: 14.0 ± 2.0; P > 0.05). The confusion-bewilderment subscales and fatigue-inertia of the POMS were also elevated post HYPER in females (P < 0.05), but not in ISO (P > 0.05) in either sex. Conclusions Hypertonic saline infusion acutely degrades mood state, and women appear to have a more pronounced response. The underlying mechanisms remain to be determined but may be related to higher copeptin levels in women. The study was registered at ClinicalTrials.gov as NCT02761434. Funding Sources Danone Research. Supporting Tables, Images and/or Graphs

Project description:IntroductionIn series of cases and animal models suffering hemorrhagic shock, the use of vasopressors has shown potential benefits regarding hemodynamics and tissue perfusion. Terlipressin is an analogue of vasopressin with a longer half-life that can be administered by bolus injection. We have previously observed that hypertonic albumin improves resuscitation following controlled hemorrhage in piglets. The aim of the present study was to analyze whether the treatment with the combination of terlipressin and hypertonic albumin can produce better hemodynamic and tissular perfusion parameters than normal saline or hypertonic albumin alone at early stages of hemorrhagic shock in an infant animal model.MethodsExperimental, randomized animal study including 39 2-to-3-month-old piglets. Thirty minutes after controlled 30 ml/kg bleed, pigs were randomized to receive either normal saline (NS) 30 ml/kg (n = 13), 5% albumin plus 3% hypertonic saline (AHS) 15 ml/kg (n = 13) or single bolus of terlipressin 15 ?g/kg i.v. plus 5% albumin plus 3% hypertonic saline 15 ml/kg (TAHS) (n = 13) over 30 minutes. Global hemodynamic and tissular perfusion parameters were compared.ResultsAfter controlled bleed a significant decrease of blood pressure, cardiac index, central venous saturation, carotid and peripheral blood flow, brain saturation and an increase of heart rate, gastric PCO2 and lactate was observed. After treatment no significant differences in most hemodynamic (cardiac index, mean arterial pressure) and perfusion parameters (lactate, gastric PCO2, brain saturation, cutaneous blood flow) were observed between the three therapeutic groups. AHS and TAHS produced higher increase in stroke volume index and carotid blood flow than NS.ConclusionsIn this pediatric animal model of hypovolemic shock, albumin plus hypertonic saline with or without terlipressin achieved similar hemodynamics and perfusion parameters than twice the volume of NS. Addition of terlipressin did not produce better results than AHS.

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Correlation of measured and calculated serum osmolality during mannitol or hypertonic saline infusion in patients after craniotomy: a study protocol and statistical analysis plan for a randomised controlled trial.

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Correlation of measured and calculated serum osmolality during mannitol or hypertonic saline infusion in patients after craniotomy: a study protocol and statistical analysis plan for a randomised controlled trial.

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