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Cochrane Database of Systematic Reviews Protocol - Intervention

Catheter type, placement and insertion techniques for preventing peritonitis in peritoneal dialysis patients

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Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

To evaluate the benefits and harms of strategies related to the catheter placement, insertion and type to prevent peritonitis in peritoneal dialysis.

Background

Peritonitis is a major complication of peritoneal dialysis and a major cause of hospitalisation (CANUSA 1996), and is associated with increased morbidity (Luzar 1990) and mortality (Digenis 1990). There is variability in reports of the incidence of peritonitis depending on age, coexisting diseases (e.g. diabetes), peritoneal dialysis modality and interventions (Yishak 2001), catheter design and implantation technique, connection methodology and the presence of nasal reservoirs of Staphylococcus aureus (Schaefer 2003). Although there has been a dramatic decrease in the rates of peritonitis from the inception of continuous ambulatory peritoneal dialysis (CAPD), rates above 0.55 episodes/patient/year are still common (Piraino 2002). These values are even higher in the paediatric population (Oxton 1994; Salusky 1997). In addition, the rate of peritonitis relapse is approximately 0.5 episodes/patient/year (Vas 2001).

Risk factors identified for peritonitis in the absence of prophylactic antibiotic treatment at the time of catheter placement are, S. aureus nasal carriage, the use of single cuffed (versus double‐cuffed) catheters, and the upward (versus downward) pointing of the tunnel (Piraino 2002). Particular populations including the immunosuppressed patients and African‐American and native American patients are also at increased risk (Holley 1993; Fine 1994; Golper 1996; Piraino 2002 ).

Evidence is still lacking relating to which intervention, if any, are better for preventing peritonitis thus reducing morbidity and mortality (Burkart 1997; Piraino 1997). The benefits of various interventions have been reported but are counterbalanced by the risks and side effects.

The following intervention options have been proposed:

  • Catheter type, insertion, and connection systems: The type and insertion techniques of catheters generate an access site for infective organisms (particularly Staphylococcus species) which are likely to cause peritonitis (Tielens 1993; Vas 2001). Different catheter types (Oxton 1994; Lye 1996; Piraino 1997), connectology (e.g. Y‐set connection system) (Stramignoni 1994), bag systems (Tielens 1993) and catheter insertion techniques (Golper 1996, Draganic 1998) may affect the incidence of peritonitis (Gokal 1999; Daly 2001).

  • Break‐in period: It has been suggested that the "break‐in period" (i.e. the time between catheter insertion and commencement of dialysis, a period necessary to allow scar tissue to form and stabilisation of the catheter in the abdomen) should be at least two weeks (CARI 2003; ISPD 2003). However, the evidence to substantiate this suggestion is not straightforward.

  • Exit‐site care: Exit‐site care (i.e. frequent applications of antiseptics such as povidone‐iodine and cleansing of the exit site using soap and water) are widely accepted but reports indicate that these techniques have not been conclusively reported to affect the overall rate of peritonitis ( Luzar 1990; Peacock 2002).

  • Immobilisation techniques: The use of catheter immobilisation techniques has also been advocated, but reports have indicated that there is still no evidence of a significant decrease in peritonitis (Turner 1992).

  • Prophylactic treatment of S. aureus nasal carriage: Some patients harbour S. aureus in their nasal cavity as part of their normal flora (Piraino 2002). This micro‐organism is well adapted to colonisation of dialysis catheters and access sites (Peacock 2002), and can potentially travel to the access point from the nasal cavity via the hands and skin, causing S. aureus peritonitis. This type of peritonitis is a major cause of morbidity and treatment failure in peritoneal dialysis patients (Piraino 2000, Annigeri 2001). Studies have been conducted on administration of anti‐microbial prophylaxis (mupirocin, rifampicin). These agents may have adverse effects and/or be the cause of antibiotic resistance (Annigeri 2001). The issue of whether antibiotics applied intranasally or topically should be a standard procedure is still debated (Bernardini 1996). Another aspect to consider as well is whether prophylactic treatments should be used in patients who have already developed resistance to some antibiotics.

In this review we will focus on the effectiveness of catheter‐related aspects (catheter type, placement and insertion techniques) for the prevention of infection in peritoneal dialysis patients. A second review (Strippoli 2004) will focus on the use of anti‐infective agents (antiseptic, antibiotic, alternate therapy) for the prevention of peritonitis.

Objectives

To evaluate the benefits and harms of strategies related to the catheter placement, insertion and type to prevent peritonitis in peritoneal dialysis.

Methods

Criteria for considering studies for this review

Types of studies

All randomised controlled trials (RCTs) and quasi‐RCTs investigating the effect of different catheter types, placement and inserting techniques for the prevention of peritonitis in peritoneal dialysis patients.

Types of participants

Adult and paediatric patients undergoing peritoneal dialysis treatment.

Types of interventions

  • Different catheter types

  • Different catheter insertion techniques

  • Different break in periods

  • Use of immobilisation techniques

Types of outcome measures

  • Peritonitis ‐ number of patients with peritonitis and peritonitis rate (dialysate count of > 100 cells/mm³ with > 50% being polymorphonuclear leukocytes)

  • Peritonitis relapse (reoccurrence of peritonitis due to the same organism within 2‐4 weeks)

  • Death due to peritonitis (data on all‐cause mortality will be also extracted)

  • Exit‐site and tunnel infection ‐ number of patients with exit‐site and tunnel infection and exit‐site and tunnel infection rates

  • Catheter removal/catheter replacement

  • Technique failure (transfer from peritoneal dialysis to haemodialysis/transplant due to peritonitis)

  • Time to first peritonitis episode

Search methods for identification of studies

Relevant trials will be obtained from the following sources (see Additional Table 1 for search terms used)
1. Cochrane Renal Group specialised register of RCTs
2. Cochrane Central Register of Controlled Trials (CENTRAL ‐ most recent issue) for any "New" records not yet incorporated in the specialised register
3. MEDLINE and Pre MEDLINE (1966 to most recent) will be searched using the above terms, combined with the optimally sensitive strategy for the identification of RCTs (Dickersin 1994) (see Cochrane Renal Group Module).
4. EMBASE (1980 to most recent) will be searched using terms similar to those used for MEDLINE and combined with a search strategy for the identification of RCTs (Lefebvre 1996).
5. Reference lists of nephrology textbooks, review articles and relevant trials.
6. Letters seeking information about unpublished or incomplete trials to investigators known to be involved in previous trials.
7. There will be no language restriction.

Open in table viewer
Table 1. ELECTRONIC SEARCH STRATEGIES

Database searched

Search terms

CENTRAL (most recent issue)

#1 peritoneal next dialysis
#2 PERITONEAL DIALYSIS (MeSH explode))
#3 pd or capd or ccpd
#4 #1 or #2 or #3
#5 PERITONITIS (MeSH)
#6 periton*
#7 #5 or #6
#8 #4 and #7

MEDLINE (1966 to most recent)

1 exp Peritoneal Dialysis/
2 peritoneal dialysis.tw.
3 (PD or CAPD or CCPD).tw.
4 or/1‐3
5 Catheters, Indwelling/
6 catheter$.tw.
7 or/5‐6
8 Peritonitis/
9 peritonitis.tw.
10 (periton$ and infect$).tw.
11 or/8‐10
12 and/4,7,11
13 pc.fs.
14 (plac$ or insert$).tw.
15 (break‐in or immobil$).tw.
16 surg$.tw.
17 or/13‐16
18 12 and 17
19 and/4,11,13
20 18 or 19

Data collection and analysis

The review will be undertaken by five reviewers (GFMS, AT, DJ, FPS, JC). The search strategy described will be used to obtain titles and abstracts of studies that might be relevant to the review. The titles and abstracts will be screened independently by (GFMS, AT), who will discard studies that are not applicable based on the inclusion criteria for this review; however studies and reviews that might include relevant data or information on trials will be retained initially and their full‐text version will be analysed. Reviewers (GFMS, AT) will independently assess retrieved abstracts and, if necessary, the full text of these studies to determine study eligibility. Data extraction will be carried out independently by the same reviewers using standard data extraction forms. Studies reported in non‐English language journals will be translated before assessment. Where more than one publication of one trial exists, only the publication with the most complete data will be included. Any further information or clarification required from the authors will be requested by written or electronic correspondence and relevant information obtained in this manner will be included in the review. Disagreements will be resolved in consultation with (JC).

STUDY QUALITY
The quality of included studies will be assessed independently by (GFMS, AT) without blinding to authorship or journal using the checklist developed by the Cochrane Renal Group. Discrepancies will be resolved by discussion with (JC). The quality items assessed which will be assessed will be allocation concealment, blinding of investigators, participants and outcome assessors, intention‐to‐treat analysis, and the completeness to follow‐up.

QUALITY CHECKLIST
1. Allocation Concealment

A. Adequate ‐ Randomisation method described that would not allow investigator/participant to know or influence intervention group before eligible participant entered in the study
B. Unclear ‐ Randomisation stated but no information on method used is available
C. Inadequate ‐ Method of randomisation used such as alternate medical record numbers or unsealed envelopes; any information in the study that indicated that investigators or participants could influence intervention group

2. Blinding
Blinding of investigators: Yes/No/not stated
Blinding of participants: Yes/No/not stated
Blinding of outcome assessor: Yes/No/not stated
Blinding of data analysis: Yes/No/not stated
The above are considered not blinded if the treatment group can be identified in > 20% of participants because of the side effects of treatment.

3. Intention‐to‐treat analysis
Yes ‐ Specifically reported by authors that intention‐to‐treat analysis was undertaken and this was confirmed on study assessment.
Yes ‐ not specifically stated but confirmed on study assessment
No ‐ Not reported and lack of intention‐to‐treat analysis confirmed on study assessment (Patients who were randomised were not included in the analysis because they did not receive the study intervention, they withdrew from the study or were not included because of protocol violation).
No ‐ Stated, but not confirmed upon study assessment
Not stated

4. Completeness to follow‐up
Per cent of participants excluded or lost to follow‐up

STATISTICAL ASSESSMENT
Results will be expressed as relative risk (RR) with 95% confidence intervals (CI) for all outcomes of the individual studies. Data will be pooled using the random effects model. For each analysis, the fixed effects model will also be evaluated to ensure robustness of the model chosen and susceptibility to outliers. Where continuous scales of measurement are used to assess the effects of treatment (time to first peritonitis episode) the weighted mean difference (WMD) will be used.

Heterogeneity will be analysed using a Chi squared test on N‐1 degrees of freedom, with an α of 0.05 used for statistical significance.

Subgroup analysis is planned to explore how possible sources of heterogeneity (pediatric vs adult population, patient's age, duration of dialysis) might influence treatment effect. It is also planned that if sufficient RCTs are identified, an attempt will be made to assess for publication bias using a funnel plot (Egger 1997).

Table 1. ELECTRONIC SEARCH STRATEGIES

Database searched

Search terms

CENTRAL (most recent issue)

#1 peritoneal next dialysis
#2 PERITONEAL DIALYSIS (MeSH explode))
#3 pd or capd or ccpd
#4 #1 or #2 or #3
#5 PERITONITIS (MeSH)
#6 periton*
#7 #5 or #6
#8 #4 and #7

MEDLINE (1966 to most recent)

1 exp Peritoneal Dialysis/
2 peritoneal dialysis.tw.
3 (PD or CAPD or CCPD).tw.
4 or/1‐3
5 Catheters, Indwelling/
6 catheter$.tw.
7 or/5‐6
8 Peritonitis/
9 peritonitis.tw.
10 (periton$ and infect$).tw.
11 or/8‐10
12 and/4,7,11
13 pc.fs.
14 (plac$ or insert$).tw.
15 (break‐in or immobil$).tw.
16 surg$.tw.
17 or/13‐16
18 12 and 17
19 and/4,11,13
20 18 or 19

Figures and Tables -
Table 1. ELECTRONIC SEARCH STRATEGIES