#DreamRCT: Ca-HIL Study
Dream RCT is a project that many of us online are involved in. The
assignment is to target the most important question you see in nephrology today
and design a trial to answer it. Per Dr Topf, “Money no object, forget about
pesky IRBs, let your mind free and create the trial which will meaningfully
push back the walls of knowledge.”
After
you post your entry at your site of choice, UKidney will
host a summary with a link for each entry and gather votes for the best. Check
out what others have proposed. This is a novel project on ideas online for
nephrology projects.
Here is my
entry.
My idea for
a dream RCT is very simple. There are many simple questions unanswered in
nephrology.
Hypercalcemia is a common problem we encounter in the hospital setting. The most
common cause usually is malignancy. While the long term treatment is dependent
on the cause, the initial treatment is usually IV fluids and diuretics,
calcitonin and so forth. The data to
give IVF followed by diuretics have been questioned. The initial observational
experiences of many physicians have driven this practice.
Usually aggressive IV hydration is
warranted sometimes even at 150-200-250 CC/HR.
Once
volume depletion is addressed, a loop diuretic MAY be used for augmentation of
calcium excretion.
A recent review and
analysis published in Annals of Internal Medicine sheds some light about use of
loop diuretic in this setting.
The
review suggests the following points:
1.
Aggressive hydration is necessary
2. Use
of diuretics without aggressive hydration might be harmful
3.
Found only 9 articles documenting the use of furosemide in hypercalcemia and
latest one published in 1983 and total was only 37 patients.
4.
Average dose was 1120mg over 24 hours ( really??)
5.
Normalization of Ca occurred in only 14 of 39 cases
6.
Study with lower doses didn't achieve normalization ( and what do we use????)
7. Complications
of other electrolyte disorders ensued
8. Finally,
recommended against the use of this agent routinely except for cases of volume
overloaded with hypercalcemia.
I
think the tile of the paper listed below nicely puts it:- Furosemide in
hypercalcemia is an unproven but common practice ( really not evidence based)
·
My suggestion is
we study this in a standardized fashion: Hypercalcemia IVF and Lasix ( HIL
study)
Venue: Multi Center
Design: Randomized control trial
Primary end point: 1. AKI 2. Need for HD
Secondary end points: 1. Length of stay, 2. Mortality
Monitor closely other
electrolyte disorders in both cohorts.
·
Inclusion Criteria
o
Age >18
o
Sex males and females
o
Primary known history
of a malignancy related hypercalcemia
·
Exclusion Criteria
o
Other causes of hypercalcemia
o
Hypercalcemia
requiring dialysis at first visit with nephrologist
o
History of known CHF
requiring diuretics on a chronic basis.
Enroll all
patients with acute hypercalcemia that are inpatient setting that are initially
evaluated for treatment with aid of a nephrologist. To make it a uniform
setting, perhaps only hypercalcemia of malignancy should be considered ( most
common cause anyway).
Randomize to
IVF ( normal saline) alone for 48 hours followed by long term therapy with
bisphosphanates, steroids or denosunab.
Or IVF (normal saline) for 48 hours and furosemide ( dose dependent escalation)
followed by long term therapy with similar agents
I think this
study or a variant of this concept should answer the question of need and use
of diuretics in treatment of hypercalcemia.
Problem is who is going to fund this?
