A Phase 2 interventional study of Intravenous Dextrose 5% solution in Hypernatremia, sponsored by Columbia University. Recruiting at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Columbia University · Phase 2, Interventional, and Treatment
The goal of this study is to show the feasibility of rapid identification, consenting, randomization, treatment, and follow-up of patients with severe hypernatremia (Na ≥ 155 mEq/L). The investigators plan to randomize 80 patients with severe hypernatremia to rapid hydration (aiming for a correction rate of 18m Eq/L/24h) versus standard of care therapy.
The aim of this study is to show the feasibility of the proposed protocol and to collect preliminary safety and efficacy data to inform a subsequent multicenter RCT powered to assess the effect of rapid hydration of patients with severe hypernatremia on 30-day survival.
Hypernatremia (high serum sodium) indicates a deficit in total body water. Hypernatremia is common in hospitalized patients and is associated with high mortality rates, directly associated with hypernatremia severity (30-70% for severe hypernatremia). The traditional approach is to correct hypernatremia slowly, not exceeding 0.5 mEq/L/hour or 10 mEq/L/day, using hypotonic intravenous fluids, to avoid hypothetical cerebral edema and related neurological complications. This treatment strategy is not supported by empirical clinical data in adults, and there are no convincing reports of neurological harm in rapidly corrected patients. Several retrospective studies have shown rapidly corrected patients had significantly lower mortality rates, without neurological complications. Whether current recommendations reflect the optimal balance between patient safety and potential harm is unknown.
This study is a feasibility RCT of 80 patients with severe hypernatremia (serum sodium ≥155 mEq/L) comparing rapid hydration to standard-of-care therapy, leading to a large, multicenter RCT powered to detect lower 30-day mortality in the rapid hydration arm. The personalized, weight-based intravenous rapid hydration protocol targets a correction rate of 18 mEq/L/day until hypernatremia is resolved (serum sodium lower than 145 mEq/L). Treatment fidelity will be assessed twice daily, with real-time interventions for any deviations from protocol. Safety monitoring will include twice daily assessments of patients' level of consciousness and presence of delirium using the Glasgow coma scale and the brief confusion assessment method (bCAM), respectively, neurological function status assessments using the modified Rankin score, brain imaging to exclude brain edema and daily chart reviews for pre-specified neurological, cardiopulmonary or other complications. This study aims to demonstrate the feasibility of patient identification, consenting, randomization, effective implementation of rapid hydration in the intervention arm (primary endpoint), adverse event monitoring and 30-day survival ascertainment in both study arms. This study will also collect preliminary safety and efficacy data informing the design of the subsequent RCT, including any neurological or cardiopulmonary adverse events, 30-day survival and length of hospitalization.
This is first pilot RCT to prospectively compare treatment strategies for adults with hypernatremia, a prevalent but understudied condition. The results of this study and the subsequent RCT will be novel and will influence clinical practice, potentially improving survival and shortening hospitalizations.
49 studies on the registry are indexed under Hypernatremia; 8 are open to participants now.
This study's planned enrollment of 80 is above the median of 64 across 32 interventional studies indexed under Hypernatremia.
Browse Hypernatremia studies →Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
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Exclusion Criteria:
Hydration with D5W solution targeting a correction rate of 18 meq/L/day (0.75 meq/L/hr) using the Adrogué-Madias formula
Drug: Intravenous Dextrose 5% solution
Standard of care correction of hypernatremia
Drug: Intravenous Dextrose 5% solution
sterile solution of glucose and water
Also known as: 5% Dextrose in Water, D5W
Sodium correction rate
The sodium correction rate will be calculated by slope fitted using least squares estimate based on all sodium measurements (on 8-hour intervals) while on hydration regimen.
Time frame: From treatment to hypernatremia correction (Na < 145 mEq/L), up to 30 days
Number of participants with hypernatremia correction within 24 hours
Number of participants who reach serum sodium \<145 mEq/L within 24 hours will be tallied
Time frame: 24 hours from treatment
Time to complete correction
Time to reach serum sodium \< 145 mEq/L
Time frame: From treatment to hypernatremia correction (Na < 145 mEq/L), up to 30 days
Number of participants in the intervention arm having no protocol deviations
To determine treatment fidelity, the research coordinator will evaluate patients randomized to the intervention arm twice daily while they are on hydration regimen. Treatment fidelity will be defined as a patient in the intervention arm having no protocol deviations. The treatment fidelity rate will be estimated using proportion and a 95% confidence lower limit.
Time frame: From treatment until correction (Na < 145 mEq/L), up to 30 days
Safety assessment completion rate
Successful collection (defined as over 85% of data points collected) of all specified safety data items, including twice daily GCS and bCAM assessments; once daily chart review for sizures, pulmonary edema, hyperglycemia, falls, aspiration pneumonia; brain CT within 48h or hypernatremia correction (Na \< 145 mEq/L).
Time frame: From treatment until correction (Na < 145 mEq/L), up to 30 days
30-day survival ascertainment rate
Proportion of patients with successful 30-day survival ascertainment. The study consent form will include permission for research coordinators to contact patients, their families or for patients who reside in long term care facilities, their caregivers, 30 days after randomization to ascertain vital status. The ascertainment rate will be estimated using proportion and a 95% confidence lower limit.
Time frame: Day 30
30-day survival rate
Number of participants who are alive at 30 days post-treatment will be tallied.
Time frame: Day 30
Length of hospitalization
Length of hospitalization is defined as the first day of admission and treatment to the day of discharge. Measured in days.
Time frame: Treatment to hospital discharge, up to 30 days
Plan to share: Yes — All de-identified study data will be submitted to Zenodo, a generalist repository that is participating in the NIH Generalist Repository Ecosystem Initiative.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Scientific data will be shared as soon as possible. Scientific data included in published manuscripts will be available at the time of publication; all other generated scientific data will be shared no later than 1 month after completion of data analysis. The study data will be stored in the repository for at least 5 years.
Access criteria: All de-identified study data will be submitted to Zenodo, a generalist repository that is participating in the NIH Generalist Repository Ecosystem Initiative. To request access of the data, researchers will use the standard processes at Zenodo.
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Feb 2029, 28 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Glucose