Background
Methods
Sites
Study population
Enrollment and follow-up
Peritonitis episodes
Endpoints
Statistical analysis
Results
Patient characteristics
Variable | HIV-Negative (n = 70) | HIV-Positive (n = 70) |
P value |
---|---|---|---|
Age (mean ± SD) | 39.1 ± 11.7 | 37.0 ± 9.4 | 0.247a
|
Weight, kg (mean ± SD) | 68.9 ± 12.6 | 66.1 ± 13.7 | 0.213a
|
Body mass index (mean ± SD) | 25.1 ± 4.7 | 24.5 ± 5.4 | 0.436a
|
Waist circumference, cm (mean ± SD) | 90.5 ± 10.9 | 90.0 ± 11.5 | 0.822a
|
Sex | |||
Female, n (%) | 30 (42.9) | 37 (52.9) | 0.236b
|
Ethnicity | |||
African, n (%) | 59 (84.3) | 70 (100.0) | 0.001c
|
Indian, n (%) | 9 (12.9) | 0 (0.0) | |
Mixed ethnicity, n (%) | 2 (2.9) | 0 (0.0) | |
Hypertension, n (%) | 63 (90.0) | 52 (74.3) | 0.015b
|
Diabetes, n (%) | 4 (5.7) | 7 (10.0) | 0.532c
|
SLE, n (%) | 4 (5.7) | 1 (1.4) | 0.366 c
|
Hepatitis B, n (%) | 7 (10.0) | 8 (12.1) | 0.737b
|
Primary residence | |||
City, n (%) | 14 (20.0) | 6 (8.6) | 0.113b
|
Townshipe, n (%) | 30 (42.8) | 39 (55.7) | |
Rural, n (%) | 23 (32.9) | 24 (34.3) | |
Education level | |||
Primary school, n (%) | 15 (21.4) | 13 (18.6) | 0.710b
|
High school, n (%) | 32 (45.7) | 31 (44.3) | |
Post-grade 12, n (%) | 20 (28.6) | 25 (35.7) | |
Employment history | |||
Unemployed, n (%) | 50 (71.4) | 53 (75.7) | 0.766b
|
Employed, n (%) | 17 (24.3) | 16 (22.9) | |
Smoking (currently) | 4 (5.71) | 7 (10.0) | 0.532c
|
Tenckhoff catheter insertion method | |||
Laparoscopic, n (%) | 66 (94.3) | 35 (50.0) | <0.001c
|
Percutaneous, n (%) | 4 (5.71) | 35 (50.0) | |
Hemoglobin, g/dL (mean ± SD) | 9.60 ± 2.01 | 8.96 ± 1.61 | 0.041a
|
Albumin, g/L (mean ± SD) | 35.3 ± 6.7 | 31.0 ± 6.6 | <0.001a
|
eGFR, ml/min/1.73 m2(mean ± SD) | 7.0 ± 3.6 | 7.1 ± 4.6 | 0.935a
|
Creatinine (μmol/l), median (IQR) | 736.5 (542–974) | 718 (598–888) | 0.917d
|
CRP (mg/L), median (IQR) | 19 (6–35) | 56.5 (21–108) | <0.001d
|
ESR (mm/hr), median (IQR) | 49 (29–66) | 88 (50–129) | <0.001d
|
Ferritin (μg/L), median (IQR) | 642 (370–1049) | 593 (381–973) | 0.858d
|
CD4 count | |||
mean (cells/μL ± SD) | 380.7 ± 235.4 | ||
CD4 < 200 cells/μL, n (%) | 14.0 (20.0) | ||
CD4 200–350 cells/μL, n (%) | 20.0 (28.6) | ||
CD4 350–500 cells/μL, n (%) | 21.0 (30.0) | ||
CD4 ≥ 500 cells/μL, n (%) | 15.0 (21.4) | ||
Viral load | |||
Median, copies/mL (IQR) | 4230 (903–91143) | ||
< 150 copies/mL, n (%) | 40 (57.1) | ||
150–1000 copies/mL, n (%) | 8 (11.4) | ||
> 1000 copies/mL, n (%) | 22 (31.4) | ||
HAART history at enrollment | |||
< 6 months, n (%) | 36 (51.4) | ||
6–12 months, n (%) | 9 (12.9) | ||
> 1 year, n (%) | 25 (35.7) | ||
HAART drug regimens | |||
3TC/EFV/ABC, n (%) | 59 (84.3) | ||
3TC/EFV/AZT, n (%) | 2 (2.9) | ||
3TC/EFV/D4T, n (%) | 3 (4.3) | ||
3TC/NVP/ABC, n (%) | 3 (4.3) | ||
3TC/Alluvia/ABC, n (%) | 1 (1.43) | ||
3TC/Aluvia/AZT, n (%) | 1 (1.43) |
Study end points
Peritonitis episodes
HIV-Negative | HIV-Positive |
P value | |
---|---|---|---|
Peritonitis episodes, n (n excluding relapse)a
| 54 (49) | 94 (81) | 0.001b
|
Participants with a peritonitis episode at 180 dayse
| 24.3% (17/70) | 51.4% (36/70) | 0.001 |
Participants with a peritonitis episode at 1 yeare
| 38.6% (27/70) | 60.0% (42/70) | 0.011 |
Participants with a peritonitis episode at 18 monthse
| 44.3% (31/70) | 65.7% (46/70) | 0.011 |
Multiple peritonitis episodes | |||
Time between peritonitis episodes (days), median (IQR) | 75 (39–107) | 55.5 (34.5–115.5) | 0.503d
|
Relapse
| 9.2% (5/54) | 13.8% (13/94) | 0.602c
|
Recurrent
| 3.7% (2/54) | 6.4% (6/94) | 0.711c
|
Repeat (Same organism) | 11.1% (6/54) | 7.4% (7/94) | 0.448b
|
Repeat (Different organism) | 18.5% (10/54) | 23.4% (22/94) | 0.487b
|
Time - Tenckhoff catheter insertion to peritonitis episode | |||
Median, days (IQR) | 184.5 (98–370) | 144.5 (63–296) | 0.124d
|
Within 180 days | 50.0% (27/54) | 56.4% (53/94) | 0.453b
|
Between 180 – 365 days | 24.1% (13/54) | 27.7% (26/94) | 0.634b
|
Between 365 – 550 days | 25.9% (14/54) | 16.0% (15/94) | 0.141b
|
PD WCC (cells/μl), median (IQR) | 1073 (360–2690) | 979 (360–2370) | 0.927d
|
Outpatient treatment | 33.3% (18/54) | 40.4% (38/94) | 0.392b
|
Inpatient treatment | 66.7% (36/54) | 59.6% (56/94) | 0.392b
|
Inpatient stay (days), median (IQR) | 9 (7–12) | 8 (7–14.5) | 0.574d
|
Peritonitis episode outcomes | |||
CAPD continuation | 70.4% (38/54) | 78.7% (74/94) | 0.254b
|
Catheter removal | 25.9% (14/54) | 17.0% (16/94) | 0.195b
|
Mortality | 3.7% (2/54) | 4.3% (4/94) | 1.000c
|
HIV-Negative | HIV-Positive |
P value | |
---|---|---|---|
All peritonitis episodes | |||
Gram-positive | 33.3% (18/54) | 36.2% (34/94) | 0.728a
|
Staphylococcus aureus
| 16.7% (9/54) | 7.4% (7/94) | 0.082a
|
Coagulase-negative staphylococcus | 16.7% (9/54) | 23.4% (22/94) | 0.332a
|
Other gram-positive bacteria | 0.0% (0/54) | 5.3% (5/94) | 0.159b
|
Gram-negative | 44.4% (24/54) | 27.7% (26/94) | 0.038a
|
Pseudomonas species | 13.0% (7/54) | 6.4% (6/94) | 0.173a
|
Klebsiella pneumoniae
| 5.6% (3/54) | 4.3% (4/94) | 0.706b
|
Acinetobacter species | 3.7% (2/54) | 10.6% (10/94) | 0.212b
|
Other gram-negative bacteria | 22.2% (12/54) | 6.4% (6/94) | 0.005a
|
Mixed organisms | 0.0% (0/54) | 1.1% (1/94) | 1.000b
|
Fungal peritonitis | 3.7% (2/54) | 5.3% (5/94) | 1.000b
|
Mycobacterium tuberculosis
| 0.0% (0/54) | 1.1% (1/94) | 1.000b
|
Culture-negative | 18.5% (10/54) | 28.7% (27/94) | 0.168a
|
Peritonitis relapse episodes | |||
Coagulase-negative staphylococcus | 1.8% (1/54) | 3.2% (3/94) | 1.000b
|
Other gram-positive bacteria | 0.0% (0/54) | 1.1% (1/94) | 1.000b
|
Pseudomonas species | 1.8% (1/54) | 3.2% (3/94) | 1.000b
|
Other gram-negative bacteria | 1.8% (1/54) | 1.1% (1/94) | 1.000b
|
Culture-negative | 3.7% (2/54)c
| 4.3% (4/94)d
| 1.000b
|
Mycobacterium tuberculosis
| 0.0% (0/54) | 1.1% (1/94) | 1.000b
|
Peritonitis-associated catheter removal | |||
Staphylococcus aureus
| 1.8% (1/54) | 0 | 0.365b
|
Pseudomonas species | 9.3% (5/54) | 1.1% (1/94) | 0.025b
|
Acinetobacter species | 1.8% (1/54) | 6.4% (6/94) | 0.423b
|
Other gram-negative bacteria | 5.6% (3/54) | 1.1% (1/94) | 0.138b
|
Culture-negative | 3.7% (2/54) | 3.2% (3/94) | 1.000b
|
Candida species | 3.7% (2/54) | 4.2% (4/94) | 1.000b
|
Mycobacterium tuberculosis
| 0 | 1.1% (1/94)e
| 1.000b
|
Peritonitis-associated mortality | |||
Coagulase-negative staphylococcus | 1.8% (1/54) | 1.1% (1/94) | 1.000b
|
Escherichia coli
| 1.8% (1/54) | 1.1% (1/94) | 1.000b
|
Fungal Peritonitis | 0 | 1.1% (1/94) | 1.000b
|
Culture-negative | 0 | 1.1% (1/94) | 1.000b
|
Peritonitis rates and proportional hazard analysis
Incidence rates per person-year | HIV-Negative | HIV-Positive | Hazard ratio (95% Conf. Interval) |
P value |
---|---|---|---|---|
All-cause peritonitisa
| 0.765 | 1.855 | HR 2.41 (1.69–3.45) | <0.001 |
Baseline CD4 count | ||||
< 200 cells/μL | 3.690 | HR 4.54 (2.35–8.76) | <0.001 | |
200–350 cells/μL | 1.940 | HR 2.61 (1.60–4.24) | <0.001 | |
> 350 cells/μL | 1.599 | HR 2.10 (1.39–3.15) | 0.001 | |
Gram-positive peritonitis | 0.262 | 0.675 | HR 2.59 (1.46–4.60) | 0.001 |
Gram-negative peritonitis | 0.353 | 0.512 | HR 1.40 (0.80–2.44) | 0.236 |
Culture-negative peritonitis | 0.150 | 0.560 | HR 3.64 (1.75–7.54) | 0.001 |
Fungal peritonitis | 0.028 | 0.089 | HR 3.25 (0.63–16.79) | 0.159 |
Peritonitis relapse
| 0.078 | 0.298 | HR 3.88 (1.37–10.94) | 0.010 |
Baseline CD4 count | ||||
< 200 cells/μL | 0.615 | HR 10.60 (1.95–57.56) | 0.006b
| |
200–350 cells/μL | 0.698 | HR 8.82 (2.90–26.90) | <0.001b
| |
≥ 350 cells/μL | 0.073 | HR 0.97 (0.19–5.00) | 0.969b
| |
Peritonitis recurrence
| 0.031 | 0.137 | HR 4.62 (0.92–23.21) | 0.063 |
Peritonitis repeat (same organism) | 0.094 | 0.160 | HR 1.81 (0.60–5.42) | 0.289 |
Peritonitis repeat (different organism) | 0.156 | 0.504 | HR 3.81 (1.80–8.09) | <0.001 |
Multiple peritonitisa
| 0.281 | 0.802 | HR 3.22 (1.82–5.71) | <0.001 |
Baseline CD4 count | ||||
< 200 cells/μL | 1.230 | HR 8.41 (2.71–26.08) | <0.001b
| |
200–350 cells/μL | 0.931 | HR 3.90 (1.86–8.18) | <0.001b
| |
> 350 cells/μL | 0.690 | HR 2.64 (1.38–5.04) | 0.003b
| |
Peritonitis hospital admissions | 0.815 | 1.814 | HR 2.19 (1.44–3.35) | <0.001 |
Peritonitis technique failurec
| 0.195 | 0.285 | HR 1.43 (0.69–2.93) | 0.335 |
All-cause technique failured
| 0.237 | 0.338 | HR 1.42 (0.73–2.73) | 0.299 |
Peritonitis mortality | 0.028 | 0.071 | HR 2.67 (0.49–14.60) | 0.258 |
All-cause mortality | 0.181 | 0.498 | HR 2.53 (1.31–4.90) | 0.006 |
Univariate Cox proportional hazards | Multivariable Cox proportional hazards | |||
---|---|---|---|---|
Variable | Hazard ratio (95% Conf. Interval) |
P value | Hazard ratio (95% Conf. Interval) |
P value |
Peritonitisd
| ||||
HIV | 2.41 (1.69–3.45) | <0.001 | 1.84 (1.07–3.16) | 0.027 |
Race | 0.19 (0.06–0.57 | 0.003 | 0.54 (0.05–5.66) | 0.607 |
Catheter insertion methoda
| 1.86 (1.28–2.71) | 0.001 | 0.63 (0.28–1.42) | 0.269 |
Catheter insertion siteb
| 2.20 (1.45–3.33 | <0.001 | 2.17 (0.84–5.58) | 0.108 |
Diabetes | 2.22 (1.35–3.66) | 0.002 | 2.09 (1.09–4.03) | 0.027 |
BMI | 1.04 (1.00–1.08 | 0.033 | 1.01 (0.95–1.09) | 0.720 |
Waist circumference | 1.02 (1.00–1.04) | 0.017 | 1.03 (0.99–1.06) | 0.151 |
Baseline hemoglobin | 0.85 (0.77–0.94) | 0.002 | 1.02 (0.88–1.19) | 0.786 |
Baseline albumin | 0.95 (0.93–0.98) | 0.001 | 0.98 (0.94–1.02) | 0.298 |
Baseline CRP | 1.00 (1.00–1.01) | 0.004 | 1.00 (1.00–1.00) | 0.652 |
Baseline CD4 count (cells/µL) | ||||
HIV-negative | Reference | |||
CD4 < 200 | 4.54 (2.35–8.76) | <0.001 | 3.28 (1.42–7.61) | 0.006 |
CD4 200–350 | 2.61 (1.6–4.24) | <0.001 | 1.18 (0.66–2.12) | 0.577 |
CD4 ≥ 350 | 2.10 (1.39–3.15) | <0.001 | 1.00 | |
Residence | ||||
City | Reference | |||
Townshipc
| 5.94 (2.17–16.25) | 0.001 | 5.56 (0.82–37.50) | 0.078 |
Rural area | 6.07 (2.19–16.8) | 0.001 | 4.68 (0.70–31.07) | 0.110 |
Technique failuree
| ||||
HIV | 1.42 (0.73–2.73) | 0.299 | 0.39 (0.14–1.11) | 0.077 |
Peritonitis | 9.29 (2.84–30.36) | <0.001 | 14.47 (2.79–75.00) | 0.001 |
Catheter insertion site | 2.33 (1.09–4.97) | 0.029 | 2.73 (0.49–15.21) | 0.252 |
Catheter insertion method | 1.62 (0.79–3.30) | 0.185 | 0.69 (0.13–3.71) | 0.663 |
Average hemoglobin | 0.72 (0.59–0.88) | 0.001 | 0.75 (0.59–0.95) | 0.016 |
Average CRP | 1.02 (1.01–1.02) | <0.001 | 1.02 (1.01–1.03) | <0.001 |