What is the evidence for use of albumin to enhance diuresis?

Comment by InpharmD Researcher

Literature evaluating the effects of albumin as an adjunct to diuresis is primarily limited to low-quality, heterogeneous studies that have observed conflicting results. Some studies have reported improved urine output and sodium excretion when combining albumin with diuretics, primarily furosemide, while other studies observed improvement in only urine output to no change. Meta-analyses assessing the effects of co-administration of albumin and diuretics have found the combination to improve both urine output and sodium excretion; however, the effects may be more apparent in those with hypoalbuminemia and may only be transient. Large-scale randomized controlled trials are needed to fully confirm the benefits and optimal dosing regimen of albumin as an adjunct to diuresis.

Background

A 2015 review notes that in various conditions resulting in edema and hypoalbuminemia, a combination of furosemide plus albumin has been observed to increase urine output and reduce edema in certain circumstances. However, the overall use of albumin in this setting remains controversial due to a lack of well-controlled, randomized trials. Additionally, other studies have not reported a benefit in different circumstances. It is believed that albumin may enhance furosemide's ability to reach its site of a secretion at the proximal tubules. Based on available data, another review recommends their combined use in two types of patients with nephrotic syndrome: those with intravascular hypovolemia or severe diuretic refractory edema. [1], [2]

Other limited studies have observed controversial results when combining furosemide and albumin in patients presenting with nephrotic syndrome. One study of five patients observed sustained diuretic effects for 1 week; however, another study that controlled their population of eight patients to individual therapy did not find improvement in urine and sodium excretion at 24 hours when furosemide and albumin were combined. Another study observed benefits of combination therapy through an increased effect on atrial natriuretic factor and mean arterial pressure along with increased excretion at 24 hours. Further, a study observing albumin use 60 minutes before furosemide observed a modest increase in diuresis but not in natriuresis. Two of these studies contained patients with hypoalbuminemia and are summarized in Tables 1 and 2. [1]

It is important to note the studies observed had small sample sizes and heterogeneous study designs. The doses utilized varied; furosemide doses ranged from 40 mg to 220 mg with concomitant equimolar concentrations of salt-poor albumin. The method of administration also varied, with albumin either being administered concurrently with the diuretic or before the diuretic. [1]

A 2021 meta-analysis evaluated the efficacy of furosemide and albumin co-administration (N= 422; 13 observational studies). Of the studies included, doses of albumin ranged from 6 to 40 g, and doses of 0.5 g/kg were also used in three studies. Doses of furosemide also varied. Furosemide with albumin co-administration was found to increase urine output by an average of 31.45 mL/hour (95% confidence interval [CI] 19.30 to 43.59) compared to furosemide treatment alone. Co-administration of furosemide and albumin also increased the average urinary sodium excretion rate to 1.76 mEq/hour (95% CI 0.83 to 2.69) compared to furosemide treatment alone. The diuretic effect of albumin and furosemide co-administration was increased in participants with low baseline serum albumin levels (<2.5 g/dL; p= 0.04) and high prescribed albumin infusion doses (> 30 g; p= 0.02). The effect was also more significant within 12 hours after administration (p= 0.01). The diuretic effect of co-administration was also improved in those with baseline creatinine levels > 1.2 mg/dL (p= 0.07), and the natriuretic effect of co-administration was improved in those with baseline estimated glomerular filtration rate <60 mL/min/1.73 m2 (p= 0.1); however, these differences were not statistically significant. This meta-analysis is limited by the low quality of studies included and the high degree of heterogeneity for outcomes of diuresis and natriuresis. [3]

Another 2014 meta-analysis evaluated the effects of co-administration of albumin and loop diuretics in hypoalbuminemic patients as a strategy to overcome diuretic resistance. Ten studies were included (8 with crossover designs) for analysis. Co-administration of albumin and furosemide led to a significant increase in the amount of urine volume (231 mL; 95% CI 135.5 to 326.5) and sodium excreted (15.9 mEq; 95% CI 4.9 to 26.8) at 8 hours. However, these differences were not significant at 24 hours. While the included studies were largely heterogeneous, a transient effect of co-administration of albumin and furosemide in hypoalbuminemic patients was identified. Large-scale randomized controlled trials are needed to further evaluate these effects. [4]

A recent meta-analysis evaluated aimed to clarify the benefits of co-administration of albumin and diuretics in mechanically ventilated patients. Three randomized controlled trials (N= 129) were included for analysis. Albumin was found to reduce the risk of hypotensive events (risk ratio [RR] 0.33; 95% CI 0.15 to 0.81); however, albumin did not significantly affect the number of mechanical ventilation days or all-cause mortality. Albumin infusion did, however, improve the P/F ratio (RR 2.83; 95% CI 1.42 to 5.67). No randomized controlled trials reported the total urine output after intervention or adverse events. Certainty of evidence for the reported outcomes was low to moderate. [5]

References:

[1] Duffy M, Jain S, Harrell N, Kothari N, Reddi AS. Albumin and Furosemide Combination for Management of Edema in Nephrotic Syndrome: A Review of Clinical Studies. Cells. 2015;4(4):622-630. Published 2015 Oct 7. doi:10.3390/cells4040622
[2] Meena J, Bagga A. Current Perspectives in Management of Edema in Nephrotic Syndrome. Indian J Pediatr. 2020;87(8):633-640. doi:10.1007/s12098-020-03252-9
[3] Lee TH, Kuo G, Chang CH, et al. Diuretic effect of co-administration of furosemide and albumin in comparison to furosemide therapy alone: An updated systematic review and meta-analysis. PLoS One. 2021;16(12):e0260312. Published 2021 Dec 1. doi:10.1371/journal.pone.0260312
[4] Kitsios GD, Mascari P, Ettunsi R, Gray AW. Co-administration of furosemide with albumin for overcoming diuretic resistance in patients with hypoalbuminemia: a meta-analysis. J Crit Care. 2014;29(2):253-259. doi:10.1016/j.jcrc.2013.10.004
[5] Itagaki Y, Yoshida N, Banno M, Momosaki R, Yamada K, Hayakawa M. Efficacy of albumin with diuretics in mechanically ventilated patients with hypoalbuminemia: A systematic review and meta-analysis. Medicine (Baltimore). 2022;101(37):e30276. doi:10.1097/MD.0000000000030276

Literature Review

A search of the published medical literature revealed 2 studies investigating the researchable question:

What is the evidence for use of albumin to enhance diuresis?

Please see Tables 1-2 for your response.


Diuretic effect of frusemide in patients with nephrotic syndrome: is it potentiated by intravenous albumin?

Design

Controlled comparison study

N= 8

Objective

To investigate the claim that infusion of albumin potentiates the diuretic effect of frusemide in patients with the nephrotic syndrome

Study Groups

Study participants (N=8)

Inclusion Criteria

Patients with nephrotic syndrome who failed to lose weight at bed rest with 40 mmol sodium diet, presented with minimal lesions and well preserved glomerular histology on renal biopsy

Exclusion Criteria

Improved or clinically worsened before study began (e.g., edema resolved or became anuric)

Methods

All participants received three different treatments in the morning at 2-day intervals: albumin 0.5 g/kg 20% solution IV for 4 hours, frusemide 60 mg bolus followed by 40 mg/h IV for 4 hours, or a combination of both infusions. Urine was collected on the days of treatment. Control urine was collected the following morning.

Duration

Presumably 6 days in total

Outcome Measures

Volume of urine, excretion of sodium, and excretion of potassium at various points

Baseline Characteristics

 

Study participants (N= 8)

 

 
  Serum creatinine range, μmol/L

106.1 to 212.2

   
  Plasma albumin range, g/dL

1.1 to 2.2

   
  Sytolic blood pressure/diastolic blood pressure range, mmHg

100/65 to 140/90

   

Results

Endpoint

Albumin

Frusemide

Albumin and frusemide

Volume of urine, mL/min

24 hours before infusion

Sometime after infusion

18 hours after infusion

 

0.69

1.24

1.11

 

0.73

8.49*

0.77

 

0.79

9.21*

1.38

Excretion of sodium, μmol/min

24 hours before infusion

Sometime after infusion

18 hours after infusion

 

19

54

50

 

15

934*

42

 

12

884*

70

Excretion of potassium, μmol/min

24 hours before infusion

Sometime after infusion

18 hours after infusion

 

19

28

20

 

20

104*

25

 

26

83*

28

*p<0.001 (versus albumin)

Study Author Conclusions

Our results do not support the use of albumin in the treatment of patients with nephrotic syndrome.

InpharmD Researcher Critique

The methods, precise measurements, and study analysis were not well-defined. Data from this study can be considered investigational at best but did not observe a benefit for combination therapy beyond the initial infusion period. Despite that, this is one of the few studies that specifically observed all patients with hypoalbuminemia.
References:

Akcicek F, Yalniz T, Basci A, Ok E, Mees EJ. Diuretic effect of frusemide in patients with nephrotic syndrome: is it potentiated by intravenous albumin?. BMJ. 1995;310(6973):162-163. doi:10.1136/bmj.310.6973.162

Does Albumin Preinfusion Potentiate Diuretic Action of Furosemide in Patients with Nephrotic Syndrome?

Design

Two-way cross-over study

N= 7

Objective

To investigate whether albumin infusion before furosemide administration could potentiate the diuretic action of furosemide

Study Groups

Study participants (N= 7)

Inclusion Criteria

Patients with nephrotic syndrome, generalized edema, and excretion of urinary protein >  3.5 g/1.73 m2/24 hr

Exclusion Criteria

Took steroids or diuretics 48 hours before start of the study, edema caused by anything other than nephrotic syndrome

Methods

Patients initially started with no treatment at baseline. Patients were given the following infusions in random order on two separate days: a sham solution followed by 160 mg of furosemide or 100 mL of 20% human albumin followed by 160 mg of furosemide. All infusions were given at 8 AM. Patients were on low-salt diet (salt < 5 g/day), and urine was collected throughout the study period.

Duration

Presumably 4 days of therapy and follow-up

Outcome Measures

Urine volume, sodium (Na), and chloride (Cl)

Baseline Characteristics

 

Age, year

Gender

Diagnosis

CrCl (mg/dL)/Albumin (g/dL)/24-hour protein excretion (mg)

Patient

1

2

3

4

5

6

7

 

53

23

17

74

65

20

36

 

male

male

male

male

male

male

female

 

FSGS

MC

FSGS

MPGN

MC

MC

FSGS 

 

2.7 / 1.8 / 13475

1.2 / 1.6 / 17869

2.7 / 1.7 / 14965

1.6 / 2.1 / 7474

1.1 / 1.7 / 6972

1.2 / 1.4 / 10874

0.6 / 1.6 / 12060

FSGS: focal segmental glomerulosclerosis; MC: minimal change; MPGN: membranoproliferative glomerulonephritis

Results

Endpoint

Furosemide alone

Furosemide after albumin infusions

 

Basal

Post-treatment

Basal

Post-treatment

Urine volume, mL/day

996 ± 230 1730 ± 199* 646 ± 91  2051 ± 199*
Urine Na, mEq/day

19.0 ± 7.2

129.5 ± 29.6* 19.8 ± 7.9 121.4 ± 38.2*
Urine Cl, mEq/day

39.1 ± 12.4

166.4 ± 29.2* 30.7 ± 8.9 148.9 ± 37.0*

* p<0.05 versus basal

Volume of urine, sodium, and chloride were not significantly different between the two groups.

Study Author Conclusions

In conclusion, these data show that albumin preinfusion potentiated diuresis, but not natriuresis, of furosemide without any change in the pharmacokinetics of the agent in patients with nephrotic syndrome.

InpharmD Researcher Critique

This is another study that had all patients with nephrotic syndrome within the range of hypoalbuminemia. However, three patients also had reduced kidney function which may have impacted the results. Overall, the study is too weak in its design and population to form a conclusion.
References:

Na KY, Han JS, Kim YS, et al. Does albumin preinfusion potentiate diuretic action of furosemide in patients with nephrotic syndrome?. J Korean Med Sci. 2001;16(4):448-454. doi:10.3346/jkms.2001.16.4.448