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Fluid Management for Postoperative Hyponatremia (DHAPS Trial)

N/A

Waitlist Available

Led By Julie Silverstein, MD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Any adult patient with a pituitary adenoma or cyst (either non-functioning, prolactin-secreting, growth hormone secreting, ACTH (adrenocorticotropic hormone)-secreting, gonadotropin secreting, or TSH secreting) scheduled to undergo pituitary resection.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-14 days after surgery

Awards & highlights

DHAPS Trial Summary

This trial will compare the effects of two different fluid management approaches on postoperative hyponatremia in patients undergoing transsphenoidal resection of a pituitary tumor or cyst.

Who is the study for?

Adults with pituitary tumors or cysts who are scheduled for surgery can join this study. It's not for those with severe heart failure, a history of certain hormone imbalances, diabetes insipidus, lack of thirst sensation, chronic low sodium levels, advanced kidney disease, or untreated adrenal or thyroid conditions.Check my eligibility

What is being tested?

The trial is testing two different ways to manage fluids after pituitary surgery to prevent low sodium levels. One group will have their fluid intake moderately restricted while the other can drink as much as they want ('ad lib').See study design

What are the potential side effects?

Possible side effects may include discomfort from limited fluid intake in the restricted group and an increased risk of delayed hyponatremia symptoms like lethargy and nausea in the ad lib group.

DHAPS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a pituitary tumor or cyst and am scheduled for surgery to remove it.

DHAPS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-14 days after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-14 days after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-14 days after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Development of hyponatremia or low sodium

DHAPS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Fluid restrictedExperimental Treatment1 Intervention

Fluids will be stopped at 8am on POD 1 and patients will be started on a moderate fluid restriction on POD #3 based on their weight (1000 cc/24 hours for patients who weigh <=100 kg and 1200 cc/24 hours for patients who weigh > 100kg)

Group II: Non Fluid RestrictedActive Control1 Intervention

No fluid restriction

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,935 Previous Clinical Trials

2,299,573 Total Patients Enrolled

Julie Silverstein, MDPrincipal InvestigatorWashington University School of Medicine

Media Library

Fluid Restricted Group Clinical Trial Eligibility Overview. Trial Name: NCT03636568 — N/A

Hyponatremia Research Study Groups: Fluid restricted, Non Fluid Restricted

Hyponatremia Clinical Trial 2023: Fluid Restricted Group Highlights & Side Effects. Trial Name: NCT03636568 — N/A

Fluid Restricted Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT03636568 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor seeking new participants at present?

"This experiment is actively recruiting, as indicated on clinicaltrials.gov, with the original post dated June 2nd 2016 and the latest update published April 11th 2022."

Answered by AI

What is the overall participant count for this research project?

"Affirmative. The information displayed on clinicaltrials.gov reveals that this medical investigation is presently recruiting participants, which commenced posting in June of 2016 and was updated as recently as April 11th 2022. 200 individuals need to be recruited from a solitary centre for the trial's completion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hyponatremia Study (Delayed Hyponatremia After Pituitary Surgery)

2016. "Hyponatremia Study (Delayed Hyponatremia After Pituitary Surgery)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03636568.

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