Trial · NCT01365793
Randomized Control Trial of Fluid Therapy for Pediatric Diabetic Ketoacidosis
NCT01365793, Phase 3, Completed, University of California, Davis; results first posted 2018-06-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Randomized Control Trial of Fluid Therapy for Pediatric Diabetic Ketoacidosis. Trials, record NCT01365793. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01365793
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Control Trial of Fluid Therapy for Pediatric Diabetic Ketoacidosis
- NCT number
- NCT01365793
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,389 participants, actual
- Lead sponsor
- University of California, Davis
- Conditions
- Cerebral Edema, Diabetic Ketoacidosis
- Interventions
- 0.45% saline replacement fluid, 0.9% saline replacement fluid, 0.45% saline intravenous fluid, 0.9% saline Intravenous fluid
- First posted
- 2011-06-03
- Last updated
- 2018-06-25
- Results first posted
- 2018-06-25
- Limitations and caveats
Fluid infusion rates for this study represent the upper and lower ends of DKA protocols in use. Rates above or below this range were not evaluated. There were fewer patients with GCS decline to \<14 than anticipated.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | the Number of Participants With Glasgow Coma Score (GCS) < 14 Within the First 24 Hours of Treatment for Diabetic Ketoacidosis (DKA) | 24 hours | The primary outcome is the binary indicator that a patient's GCS score drops below 14 (i.e. abnormal score) within the first 24 hours of treatment of DKA. There will be two treatment factors: sodium concentration of re-hydration fluids and rate of rehydration. These effects will be tested separately, using the Mantel-Haenszel chi-square test, stratified by hospital, and by the other main factor. |
| Secondary | Frequency of Clinically Apparent Brain Injury | 24 hours | Deterioration in neurological status requiring interventions such as hyperosmolar therapy or endotracheal intubation, or resulting in death. This outcome was determined by an adjudication committee. |
| Secondary | Hourly Improvement in Forward and Backward Digit Span Scores During DKA Treatment (Mean Difference Per Hour) | 24 hours | The Digit Span subtest is adapted from the Wechsler Intelligence Scale for Children, 4th version (WISC-IV) and it assesses working memory. It consists of a Digit Span Forward task in which individuals are asked to repeat numbers in the same sequence as they were presented verbally and a Digit Span Backward task in which participants repeat the numbers in the reversed order to which they were heard. Each task yields a score ranging from 0 to 16. Higher scores represent better outcomes for this test. The trajectory of digit span scores during the course of the hospitalization was used to assess improvements in mental status and whether these varied systematically as a function of treatment protocol. Digit span measurements were collected every four hours during waking hours (7AM to 10PM). The measure analyzed is the average linear change in scores between enrollment and either 24-hours or DKA resolution, whichever occurred first. |
| Secondary | Mean Scores on Tests of Memory Capacity 3 Months After Recovery From DKA. | 3 months | Contextual memory was assessed via color and spatial-position tasks. Color-Task: black-ink items on a white square background were shown on a computer screen with a colored border. Subjects were asked to remember the item and the item's border color. Items were shown for 1 second, followed by a 1-second interval in which a fixation point was shown. Then, subjects were given a self-paced recognition test including studied drawings and new drawings shown in random order with no color border. Subjects determined if they had seen the drawing before. For recognized drawings, subjects reported the previously shown border color. Spatial-Position task: identical to the color task except that the items instead varied in their spatial position on the computer screen. The item-context association rate is the rate of correct item-color and item-spatial position recalled over the total of previously viewed items correctly recognized. Score range: 0-1 with higher scores indicating a better outcome. |
| Secondary | Intelligence Quotient (IQ) Testing | 3 months | IQ was assessed with the WASI (6-18 year olds) or WPPSI-III (3-5 year olds) at the 3 month follow-up visit. The Wechsler Abbreviated Scale of Intelligence (WASI) is a measure of IQ designed for individuals aged 6 to 89. The WASI includes four subtests; the Block Design and Matrix Reasoning tests measure Performance IQ, and the Vocabulary and Similarities tests measure Verbal IQ. Full scale IQ was computed from these scores and used for analyses. Scores typically vary from 75 to 135 with higher scores representing a better outcome. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | the Number of Participants With Glasgow Coma Score (GCS) < 14 Within the First 24 Hours of Treatment for Diabetic Ketoacidosis (DKA) | 24 hours | Patients with a GCS of 14 or 15 at randomization | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Frequency of Clinically Apparent Brain Injury | 24 hours | All randomized patients. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Hourly Improvement in Forward and Backward Digit Span Scores During DKA Treatment (Mean Difference Per Hour) | 24 hours | All randomized patients with digit span measured during DKA | Digit Span Change per Hour | MEAN |
| SECONDARY | Mean Scores on Tests of Memory Capacity 3 Months After Recovery From DKA. | 3 months | All randomized subjects aged 6 years old and older with 3-month follow-up and successful completion of memory score tests, and d-prime (a measure of chance agreement) \>0.50 | Item-context association rate | MEAN |
| SECONDARY | Intelligence Quotient (IQ) Testing | 3 months | All randomized subjects aged 3 years and older with 3-month follow-up and successful completion of IQ testing. | IQ points | MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| the Number of Participants With Glasgow Coma Score (GCS) < 14 Within the First 24 Hours of Treatment for Diabetic Ketoacidosis (DKA) | Rapid Rehydration Using 0.45% Saline Replacement Fluid | 10 | Participants | ||
| the Number of Participants With Glasgow Coma Score (GCS) < 14 Within the First 24 Hours of Treatment for Diabetic Ketoacidosis (DKA) | Rapid Rehydration Using 0.9% Saline Replacement Fluid | 11 | Participants | ||
| the Number of Participants With Glasgow Coma Score (GCS) < 14 Within the First 24 Hours of Treatment for Diabetic Ketoacidosis (DKA) | Slower Rehydration Using 0.45% Saline Replacement Fluid | 11 | Participants | ||
| the Number of Participants With Glasgow Coma Score (GCS) < 14 Within the First 24 Hours of Treatment for Diabetic Ketoacidosis (DKA) | Slower Rehydration Using 0.9% Saline Replacement Fluid | 16 | Participants | ||
| Frequency of Clinically Apparent Brain Injury | Rapid Rehydration Using 0.45% Saline Replacement Fluid | 2 | Participants | ||
| Frequency of Clinically Apparent Brain Injury | Rapid Rehydration Using 0.9% Saline Replacement Fluid | 2 | Participants | ||
| Frequency of Clinically Apparent Brain Injury | Slower Rehydration Using 0.45% Saline Replacement Fluid | 5 | Participants | ||
| Frequency of Clinically Apparent Brain Injury | Slower Rehydration Using 0.9% Saline Replacement Fluid | 3 | Participants | ||
| Hourly Improvement in Forward and Backward Digit Span Scores During DKA Treatment (Mean Difference Per Hour) | Rapid Rehydration Using 0.45% Saline Replacement Fluid | Digit span recall test Forward slope | 0.065 | Standard Error 0.010 | Digit Span Change per Hour |
| Hourly Improvement in Forward and Backward Digit Span Scores During DKA Treatment (Mean Difference Per Hour) | Rapid Rehydration Using 0.9% Saline Replacement Fluid | Digit span recall test Forward slope | 0.058 | Standard Error 0.010 | Digit Span Change per Hour |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rapid Rehydration Using 0.45% Saline Replacement Fluid | 344 | |
| Overall Study | STARTED | Rapid Rehydration Using 0.9% Saline Replacement Fluid | 351 | |
| Overall Study | STARTED | Slower Rehydration Using 0.45% Saline Replacement Fluid | 345 | |
| Overall Study | STARTED | Slower Rehydration Using 0.9% Saline Replacement Fluid | 349 | |
| Overall Study | COMPLETED | Rapid Rehydration Using 0.45% Saline Replacement Fluid | 342 | |
| Overall Study | COMPLETED | Rapid Rehydration Using 0.9% Saline Replacement Fluid | 344 | |
| Overall Study | COMPLETED | Slower Rehydration Using 0.45% Saline Replacement Fluid | 338 | |
| Overall Study | COMPLETED | Slower Rehydration Using 0.9% Saline Replacement Fluid | 347 | |
| Overall Study | NOT COMPLETED | Rapid Rehydration Using 0.45% Saline Replacement Fluid | 2 | |
| Overall Study | NOT COMPLETED | Rapid Rehydration Using 0.9% Saline Replacement Fluid | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events816
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Coagulopathy | Blood and lymphatic system disorders | Rapid Rehydration Using 0.45% Saline Replacement Fluid | 1 | 342 | 1 |
| other | Coagulopathy | Blood and lymphatic system disorders | Rapid Rehydration Using 0.9% Saline Replacement Fluid | 0 | 344 | 0 |
| other | Coagulopathy | Blood and lymphatic system disorders | Slower Rehydration Using 0.45% Saline Replacement Fluid | 0 | 338 | 0 |
| other | Coagulopathy | Blood and lymphatic system disorders | Slower Rehydration Using 0.9% Saline Replacement Fluid | 0 | 347 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Rapid Rehydration Using 0.45% Saline Replacement Fluid | 0 | 342 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Rapid Rehydration Using 0.9% Saline Replacement Fluid | 1 | 344 | 1 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Slower Rehydration Using 0.45% Saline Replacement Fluid | 0 | 338 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Slower Rehydration Using 0.9% Saline Replacement Fluid | 0 | 347 | 0 |
| other | Bradycardia | Cardiac disorders | Rapid Rehydration Using 0.45% Saline Replacement Fluid | 1 | 342 | 1 |
| other | Bradycardia | Cardiac disorders | Rapid Rehydration Using 0.9% Saline Replacement Fluid | 1 | 344 | 1 |
1 to 10 of 816Source ClinicalTrials.gov
See all 816 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rapid Rehydration Using 0.45% Saline Replacement Fluid | 1 | 342 |
| Total, all-cause mortality | Rapid Rehydration Using 0.9% Saline Replacement Fluid | 0 | 344 |
| Total, all-cause mortality | Slower Rehydration Using 0.45% Saline Replacement Fluid | 0 | 338 |
| Total, all-cause mortality | Slower Rehydration Using 0.9% Saline Replacement Fluid | 0 | 347 |
| Total, other adverse events | Rapid Rehydration Using 0.45% Saline Replacement Fluid | 112 | 342 |
| Total, other adverse events | Rapid Rehydration Using 0.9% Saline Replacement Fluid | 124 | 344 |
| Total, other adverse events | Slower Rehydration Using 0.45% Saline Replacement Fluid | 117 | 338 |
| Total, other adverse events | Slower Rehydration Using 0.9% Saline Replacement Fluid | 129 | 347 |
| Total, serious adverse events | Rapid Rehydration Using 0.45% Saline Replacement Fluid | 5 | 342 |
| Total, serious adverse events | Rapid Rehydration Using 0.9% Saline Replacement Fluid | 4 | 344 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23490311 | BACKGROUND |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01HD062417 | Fluid Therapy and Cerebral Injury in Pediatric Diabetic Ketoacidosis | KUPPERMANN, NATHAN; GLASER, NICOLE S | UNIVERSITY OF CALIFORNIA AT DAVIS | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2012 to 2014 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Secondary outcome | ConductCognition |
| Matrix Reasoning | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01365793
GET https://conductscience.org/api/trials/v1/NCT01365793/results?page=2