---
title: 8.4% Sodium Bicarbonate Locks in Intestinal Failure
nct_id: NCT05813535
overall_status: UNKNOWN
phase: PHASE2
sponsor: Riad Rahhal
study_type: INTERVENTIONAL
primary_condition: Intestinal Failure
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05813535.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05813535"
ct_last_update_post_date: 2023-11-18
last_seen_at: "2026-05-12T06:00:21.384Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 8.4% Sodium Bicarbonate Locks in Intestinal Failure

**Official Title:** Sodium Bicarb Locks in Intestinal Failure

**NCT ID:** [NCT05813535](https://clinicaltrials.gov/study/NCT05813535)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 15
- **Lead Sponsor:** Riad Rahhal
- **Conditions:** Intestinal Failure, CRBSI - Catheter Related Bloodstream Infection
- **Start Date:** 2022-12-01
- **Completion Date:** 2024-12
- **CT.gov Last Update:** 2023-11-18

## Brief Summary

We plan to include children with intestinal failure, a condition where the gut is not functioning properly, leading these children to need central venous catheters (line that goes through the skin into the blood stream) for nutritional support and hydration. Such patients have a very high risk for catheter infection. The study will include placing an agent (sodium bicarbonate) into the central catheter when the catheter is not in use. This is referred to as a lock. The lock would be used daily and removed when patients start their nutritional support and hydration through the catheter.

## Detailed Description

Children with intestinal failure who rely on a silicone based central venous catheter for parenteral nutrition to provide nutritional support and hydration will be invited to participate in this study. The intervention will offer use of a specific catheter lock solution (8.4% sodium bicarbonate) when the catheter is not in use. This includes daily lock use with removal of the lock at end of dwell time.

## Eligibility

- **Minimum age:** 1 Year
- **Maximum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Subject fulfills diagnosis of intestinal failure with a central venous catheter in place used daily on outpatient basis for intravenous nutrition and /or intravenous hydration
* Subject is less than 18 years of age at the time of study entry
* Subject with history of at least 1 documented catheter related blood stream infection (verified by blood culture)
```

## Arms

- **Baseline** (OTHER) — Patient on heparin locks when off venous nutrition

## Interventions

- **Sodium bicarb lock** (DRUG) — 8.4% sodium bicarb locks when off venous nutrition

## Primary Outcomes

- **Rate of catheter related bloodstream infections** _(time frame: Through study completion, an average of 1 year)_ — Number of infections per 1000 catheter days

## Locations (1)

- University of Iowa, Iowa City, Iowa, United States — _RECRUITING_

## Recent Field Changes (last 30 days)

- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of iowa|iowa city|iowa|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05813535.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05813535*  
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